Trial Outcomes & Findings for Study of Pembrolizumab (MK-3475) vs. Best Supportive Care in Participants With Previously Systemically Treated Advanced Hepatocellular Carcinoma (MK-3475-240/KEYNOTE-240) (NCT NCT02702401)
NCT ID: NCT02702401
Last Updated: 2022-09-29
Results Overview
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). PD was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesion was also considered PD. If there was no disease progression or death, participants were censored at the date of their last disease assessment. The PFS was analyzed using the product-limit (Kaplan-Meier) method for censored data. Final analyses for PFS was performed for the first pembrolizumab course at protocol specified cut off of 26-Mar-2018.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
413 participants
Primary outcome timeframe
Through database cutoff date of 26-Mar-2018 (Up to approximately 21 months)
Results posted on
2022-09-29
Participant Flow
Although 278 participants were randomized to receive pembrolizumab and 135 to receive placebo, 1 participant in the placebo group received pembrolizumab in error. The efficacy population included all participants as randomized and the safety population was adjusted to account for actual treatment received (pembrolizumab = 279, placebo =134).
Final analyses for Progression Free Survival (PFS) was done at the protocol-specified cut off of 26-Mar-2018 and final analysis of all other primary and secondary outcome measures was done at the protocol-specified cutoff of 02-Jan-2019. Per protocol, response/progression or adverse events during the second pembrolizumab course were not counted towards efficacy outcome measures or safety outcome measures.
Participant milestones
| Measure |
Pembrolizumab + Best Supportive Care
Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS best supportive care (BSC). Participants who complete 35 administrations or achieve a complete response (CR) but progress after discontinuation can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Best Supportive Care
Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS BSC.
|
|---|---|---|
|
Overall Study
STARTED
|
278
|
135
|
|
Overall Study
Treated
|
278
|
135
|
|
Overall Study
Received Second Course
|
7
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
278
|
135
|
Reasons for withdrawal
| Measure |
Pembrolizumab + Best Supportive Care
Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS best supportive care (BSC). Participants who complete 35 administrations or achieve a complete response (CR) but progress after discontinuation can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Best Supportive Care
Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS BSC.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Sponsor Decision
|
19
|
3
|
|
Overall Study
Physician Decision
|
1
|
2
|
|
Overall Study
Death
|
242
|
125
|
|
Overall Study
Withdrawal by Subject
|
15
|
5
|
Baseline Characteristics
Study of Pembrolizumab (MK-3475) vs. Best Supportive Care in Participants With Previously Systemically Treated Advanced Hepatocellular Carcinoma (MK-3475-240/KEYNOTE-240)
Baseline characteristics by cohort
| Measure |
Pembrolizumab + Best Supportive Care
n=278 Participants
Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS best supportive care (BSC). Participants who complete 35 administrations or achieve a complete response (CR) but progress after discontinuation can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Best Supportive Care
n=135 Participants
Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS BSC.
|
Total
n=413 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.6 Years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
64.4 Years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
65.2 Years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
226 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
338 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
233 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
346 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
23 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
113 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
143 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
213 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of enrollment
Asia without Japan
|
67 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Region of enrollment
European Union
|
96 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Region of enrollment
Japan
|
40 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Region of enrollment
United States
|
21 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Region of enrollment
Others
|
54 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Macrovascular invasion
Yes
|
36 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Macrovascular invasion
No
|
242 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
361 Participants
n=5 Participants
|
|
Alpha-fetoprotein level
<200 ng/mL
|
149 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
226 Participants
n=5 Participants
|
|
Alpha-fetoprotein level
≥200 ng/mL
|
129 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through database cutoff date of 26-Mar-2018 (Up to approximately 21 months)Population: The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). PD was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesion was also considered PD. If there was no disease progression or death, participants were censored at the date of their last disease assessment. The PFS was analyzed using the product-limit (Kaplan-Meier) method for censored data. Final analyses for PFS was performed for the first pembrolizumab course at protocol specified cut off of 26-Mar-2018.
Outcome measures
| Measure |
Pembrolizumab + Best Supportive Care
n=278 Participants
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS BSC. Participants who complete 35 administrations or achieve a complete response (CR) but progress after discontinuation can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Best Supportive Care
n=135 Participants
Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS BSC.
|
|---|---|---|
|
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
|
3.0 Months
Interval 2.8 to 4.1
|
2.8 Months
Interval 2.5 to 4.1
|
PRIMARY outcome
Timeframe: Through database cutoff date of 02-Jan-2019 (Up to approximately 30 months)Population: The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.
OS was determined for all participants and was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last follow-up. The OS was analyzed using the product-limit (Kaplan-Meier) method for censored data. Final analyses for OS was performed for the first pembrolizumab course at protocol specified cut off of 02-Jan-2019.
Outcome measures
| Measure |
Pembrolizumab + Best Supportive Care
n=278 Participants
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS BSC. Participants who complete 35 administrations or achieve a complete response (CR) but progress after discontinuation can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Best Supportive Care
n=135 Participants
Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS BSC.
|
|---|---|---|
|
Overall Survival (OS)
|
13.9 Months
Interval 11.6 to 16.0
|
10.6 Months
Interval 8.3 to 13.5
|
SECONDARY outcome
Timeframe: Through database cutoff date of 02-Jan-2019 (Up to approximately 30 months)Population: The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.
ORR was determined in all participants and was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). Participants with missing data were considered non-responders. The ORR was analyzed using the Miettinen \& Nurminen method. The percentage of participants who experienced a CR or PR per RECIST 1.1 is presented. Final analyses for ORR was performed for the first pembrolizumab course at protocol specified cut off of 02-Jan-2019.
Outcome measures
| Measure |
Pembrolizumab + Best Supportive Care
n=278 Participants
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS BSC. Participants who complete 35 administrations or achieve a complete response (CR) but progress after discontinuation can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Best Supportive Care
n=135 Participants
Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS BSC.
|
|---|---|---|
|
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
|
18.3 Percentage of participants
Interval 14.0 to 23.4
|
4.4 Percentage of participants
Interval 1.6 to 9.4
|
SECONDARY outcome
Timeframe: Through database cutoff date of 02-Jan-2019 (Up to approximately 30 months)Population: The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.
DCR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions), Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), or Stable Disease (SD) per RECIST 1.1 after ≥6 weeks as assessed by Blinded Independent Central Review (BICR). The DCR was analyzed using the Miettinen \& Nurminen method. The percentage of participants who experienced a CR, PR, or SD is presented. Final analyses for DCR was performed for the first pembrolizumab course at protocol specified cut off of 02-Jan-2019.
Outcome measures
| Measure |
Pembrolizumab + Best Supportive Care
n=278 Participants
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS BSC. Participants who complete 35 administrations or achieve a complete response (CR) but progress after discontinuation can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Best Supportive Care
n=135 Participants
Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS BSC.
|
|---|---|---|
|
Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
|
62.2 Percentage of participants
Interval 56.2 to 68.0
|
53.3 Percentage of participants
Interval 44.6 to 62.0
|
SECONDARY outcome
Timeframe: Through database cutoff date of 02-Jan-2019 (Up to approximately 30 months)Population: The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.
TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). PD was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesion was also considered PD. If there was no documented disease progression, TTP was censored at last tumor assessment date. The TTP was analyzed using the product-limit (Kaplan-Meier) method for censored data. TTP per RECIST 1.1 is presented for all participants. Final analyses for TTP was performed for the first pembrolizumab course at protocol specified cut off of 02-Jan-2019.
Outcome measures
| Measure |
Pembrolizumab + Best Supportive Care
n=278 Participants
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS BSC. Participants who complete 35 administrations or achieve a complete response (CR) but progress after discontinuation can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Best Supportive Care
n=135 Participants
Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS BSC.
|
|---|---|---|
|
Time to Progression (TTP) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
|
3.8 Months
Interval 2.8 to 4.4
|
2.8 Months
Interval 1.6 to 2.9
|
SECONDARY outcome
Timeframe: From time of first documented evidence of CR or PR through database cutoff date of 02-Jan-2019 (Up to approximately 30 months)Population: The analysis population included all randomized participants who demonstrated at least a partial response. Participants were included in the treatment group to which they were randomized.
DOR was determined in participants who demonstrated a Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). DOR was defined as time from first documented evidence of a CR or PR until progressive disease (PD) or death. Participants who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment. PD was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesion was also considered PD. The DOR was analyzed using the product-limit (Kaplan-Meier) method for censored data. Final analyses for DOR was performed for the first pembrolizumab course at protocol specified cut off of 02-Jan-2019.
Outcome measures
| Measure |
Pembrolizumab + Best Supportive Care
n=51 Participants
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS BSC. Participants who complete 35 administrations or achieve a complete response (CR) but progress after discontinuation can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Best Supportive Care
n=6 Participants
Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS BSC.
|
|---|---|---|
|
Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
|
13.8 Months
Interval 6.9 to
The upper 95% confidence interval could not be estimated according to the prespecified methodology stipulated in the protocol.
|
NA Months
Interval 2.8 to
The Median was not reached and the upper 95% confidence interval could not be estimated according to the prespecified methodology stipulated in the protocol.
|
SECONDARY outcome
Timeframe: Through database cutoff date of 02-Jan-2019 (Up to approximately 30 months)Population: The analysis population included participants who received ≥1 dose of study treatment. Participants were grouped by actual treatment received.
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented. Final analyses for AE was performed for the first pembrolizumab course at protocol specified cut off of 02-Jan-2019.
Outcome measures
| Measure |
Pembrolizumab + Best Supportive Care
n=279 Participants
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS BSC. Participants who complete 35 administrations or achieve a complete response (CR) but progress after discontinuation can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Best Supportive Care
n=134 Participants
Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS BSC.
|
|---|---|---|
|
Number of Participants Who Experienced At Least One Adverse Event (AE)
|
269 Participants
|
121 Participants
|
SECONDARY outcome
Timeframe: From Day 1 through end of treatment (Up to approximately 24 months)Population: The analysis population included participants who received ≥1 dose of study treatment. Participants were grouped by actual treatment received.
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE is presented. Final analyses for AE was performed for the first pembrolizumab course at protocol specified cut off of 02-Jan-2019.
Outcome measures
| Measure |
Pembrolizumab + Best Supportive Care
n=279 Participants
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS BSC. Participants who complete 35 administrations or achieve a complete response (CR) but progress after discontinuation can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Best Supportive Care
n=134 Participants
Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS BSC.
|
|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
|
48 Participants
|
12 Participants
|
Adverse Events
Pembrolizumab + Best Supportive Care
Serious events: 106 serious events
Other events: 240 other events
Deaths: 246 deaths
Placebo + Best Supportive Care
Serious events: 37 serious events
Other events: 109 other events
Deaths: 124 deaths
Pembrolizumab Second Course
Serious events: 3 serious events
Other events: 7 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Pembrolizumab + Best Supportive Care
n=279 participants at risk
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS BSC. Participants who complete 35 administrations or achieve a complete response (CR) but progress after discontinuation can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Best Supportive Care
n=134 participants at risk
Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS BSC.
|
Pembrolizumab Second Course
n=7 participants at risk
Participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 17 cycles (up to \~1 year).
|
|---|---|---|---|
|
Vascular disorders
Hypotension
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
3/279 • Number of events 3 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
3.7%
5/134 • Number of events 6 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/279 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Cardiac disorders
Atrial fibrillation
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
1.5%
2/134 • Number of events 2 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Cardiac disorders
Cardiac arrest
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Cardiac disorders
Myocardial infarction
|
0.72%
2/279 • Number of events 2 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/279 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Endocrine disorders
Hypophysitis
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Endocrine disorders
Hypothyroidism
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
14.3%
1/7 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/279 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Eye disorders
Macular hole
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/279 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/279 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.72%
2/279 • Number of events 2 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Ascites
|
4.7%
13/279 • Number of events 14 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
3.7%
5/134 • Number of events 5 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Colitis
|
0.72%
2/279 • Number of events 2 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
14.3%
1/7 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Constipation
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.72%
2/279 • Number of events 2 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Diverticular fistula
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/279 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/279 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
14.3%
1/7 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
1.1%
3/279 • Number of events 4 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.1%
3/279 • Number of events 3 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Varices oesophageal
|
1.1%
3/279 • Number of events 3 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
General disorders
Chest pain
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
General disorders
Death
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
General disorders
Fatigue
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
General disorders
General physical health deterioration
|
0.72%
2/279 • Number of events 2 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
General disorders
Influenza like illness
|
0.00%
0/279 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/279 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
General disorders
Pyrexia
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.72%
2/279 • Number of events 2 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/279 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Hepatobiliary disorders
Cholestasis
|
0.72%
2/279 • Number of events 2 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.72%
2/279 • Number of events 2 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/279 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.72%
2/279 • Number of events 2 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
1.5%
2/134 • Number of events 2 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.72%
2/279 • Number of events 2 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
1.1%
3/279 • Number of events 3 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Hepatobiliary disorders
Jaundice
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Immune system disorders
Contrast media allergy
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Infections and infestations
Bronchitis
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Infections and infestations
Cellulitis
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Infections and infestations
Gastroenteritis
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/279 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Infections and infestations
Hepatitis C
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Infections and infestations
Infection
|
0.72%
2/279 • Number of events 2 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Infections and infestations
Influenza
|
0.00%
0/279 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Infections and infestations
Liver abscess
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Infections and infestations
Mycobacterial infection
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Infections and infestations
Peritonitis
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Infections and infestations
Peritonitis bacterial
|
0.72%
2/279 • Number of events 2 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Infections and infestations
Pleural infection
|
0.00%
0/279 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Infections and infestations
Pneumonia
|
2.2%
6/279 • Number of events 6 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
2.2%
3/134 • Number of events 3 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Infections and infestations
Pneumonia bacterial
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/279 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Infections and infestations
Sepsis
|
0.72%
2/279 • Number of events 2 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Infections and infestations
Thrombophlebitis septic
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Infections and infestations
Urinary tract infection
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/279 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Investigations
Alanine aminotransferase increased
|
2.5%
7/279 • Number of events 7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Investigations
Aspartate aminotransferase increased
|
3.2%
9/279 • Number of events 9 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
3.0%
4/134 • Number of events 4 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Investigations
Blood bilirubin increased
|
2.9%
8/279 • Number of events 8 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
1.5%
2/134 • Number of events 3 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Investigations
Blood creatinine increased
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.36%
1/279 • Number of events 2 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/279 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/279 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/279 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/279 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
14.3%
1/7 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/279 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/279 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/279 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
14.3%
1/7 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Insulinoma
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral neoplasm
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/279 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour rupture
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Nervous system disorders
Cerebral infarction
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.36%
1/279 • Number of events 2 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Nervous system disorders
Seizure
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Nervous system disorders
Syncope
|
0.00%
0/279 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Psychiatric disorders
Mental status changes
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.1%
3/279 • Number of events 3 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/279 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Renal and urinary disorders
Renal failure
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.36%
1/279 • Number of events 2 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/279 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.1%
3/279 • Number of events 3 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.72%
2/279 • Number of events 2 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/279 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.72%
2/279 • Number of events 2 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.72%
2/279 • Number of events 2 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/279 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
Other adverse events
| Measure |
Pembrolizumab + Best Supportive Care
n=279 participants at risk
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS BSC. Participants who complete 35 administrations or achieve a complete response (CR) but progress after discontinuation can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Best Supportive Care
n=134 participants at risk
Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS BSC.
|
Pembrolizumab Second Course
n=7 participants at risk
Participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 17 cycles (up to \~1 year).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.7%
27/279 • Number of events 29 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
8.2%
11/134 • Number of events 18 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
14.3%
1/7 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Endocrine disorders
Hypothyroidism
|
4.7%
13/279 • Number of events 14 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
5.2%
7/134 • Number of events 7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.0%
39/279 • Number of events 51 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
6.7%
9/134 • Number of events 9 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.0%
25/279 • Number of events 27 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
7.5%
10/134 • Number of events 14 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Ascites
|
5.4%
15/279 • Number of events 15 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
6.0%
8/134 • Number of events 8 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
28/279 • Number of events 33 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
11.2%
15/134 • Number of events 16 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
17.6%
49/279 • Number of events 74 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
14.9%
20/134 • Number of events 24 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.8%
5/279 • Number of events 6 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
1.5%
2/134 • Number of events 2 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
14.3%
1/7 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Nausea
|
11.8%
33/279 • Number of events 41 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
14.9%
20/134 • Number of events 21 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.00%
0/279 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
14.3%
1/7 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Toothache
|
1.1%
3/279 • Number of events 4 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
14.3%
1/7 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
9.3%
26/279 • Number of events 41 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
3.7%
5/134 • Number of events 9 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
General disorders
Asthenia
|
9.3%
26/279 • Number of events 35 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
11.2%
15/134 • Number of events 17 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
General disorders
Fatigue
|
18.3%
51/279 • Number of events 60 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
23.1%
31/134 • Number of events 32 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
28.6%
2/7 • Number of events 2 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
General disorders
Oedema peripheral
|
11.5%
32/279 • Number of events 39 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
12.7%
17/134 • Number of events 20 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
14.3%
1/7 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
General disorders
Pyrexia
|
9.0%
25/279 • Number of events 27 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
11.2%
15/134 • Number of events 22 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Infections and infestations
Herpes zoster
|
0.72%
2/279 • Number of events 2 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
14.3%
1/7 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.1%
3/279 • Number of events 3 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
14.3%
1/7 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Investigations
Alanine aminotransferase increased
|
16.1%
45/279 • Number of events 49 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
9.0%
12/134 • Number of events 12 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Investigations
Aspartate aminotransferase increased
|
19.7%
55/279 • Number of events 58 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
13.4%
18/134 • Number of events 21 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.2%
20/279 • Number of events 20 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
6.7%
9/134 • Number of events 9 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Investigations
Blood bilirubin increased
|
16.5%
46/279 • Number of events 59 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
11.9%
16/134 • Number of events 18 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.5%
18/279 • Number of events 19 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
5.2%
7/134 • Number of events 7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Investigations
Platelet count decreased
|
4.7%
13/279 • Number of events 16 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
1.5%
2/134 • Number of events 2 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
14.3%
1/7 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.8%
47/279 • Number of events 51 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
15.7%
21/134 • Number of events 23 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.3%
12/279 • Number of events 21 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
5.2%
7/134 • Number of events 7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.5%
21/279 • Number of events 25 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
5.2%
7/134 • Number of events 7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.8%
33/279 • Number of events 37 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
12.7%
17/134 • Number of events 19 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.4%
29/279 • Number of events 31 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
9.7%
13/134 • Number of events 14 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.8%
5/279 • Number of events 8 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
2.2%
3/134 • Number of events 3 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
14.3%
1/7 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.4%
4/279 • Number of events 4 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
14.3%
1/7 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Nervous system disorders
Headache
|
7.2%
20/279 • Number of events 23 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
3.7%
5/134 • Number of events 7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Psychiatric disorders
Insomnia
|
4.3%
12/279 • Number of events 12 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
6.0%
8/134 • Number of events 10 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Psychiatric disorders
Sleep disorder
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
14.3%
1/7 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Renal and urinary disorders
Dysuria
|
0.72%
2/279 • Number of events 2 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
14.3%
1/7 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Reproductive system and breast disorders
Penile erythema
|
0.36%
1/279 • Number of events 2 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/134 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
14.3%
1/7 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.6%
24/279 • Number of events 32 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
17.9%
24/134 • Number of events 27 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
14.3%
1/7 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.8%
19/279 • Number of events 19 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
10.4%
14/134 • Number of events 16 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.72%
2/279 • Number of events 2 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.75%
1/134 • Number of events 2 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
14.3%
1/7 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.36%
1/279 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
2.2%
3/134 • Number of events 3 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
14.3%
1/7 • Number of events 1 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
19.0%
53/279 • Number of events 66 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
12.7%
17/134 • Number of events 18 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
35/279 • Number of events 42 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
5.2%
7/134 • Number of events 8 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
|
Vascular disorders
Hypertension
|
3.6%
10/279 • Number of events 10 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
6.0%
8/134 • Number of events 14 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
0.00%
0/7 • Through database cutoff date of 22-Sep-2021 (Up to approximately 59.3 months).
All participants who received at ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" unrelated to study drug are excluded as AEs. Due to a dosing error (a participant randomized to the placebo group received pembrolizumab), the population for all-cause mortality and AEs was adjusted to account for actual treatment received.
|
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 The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER