Trial Outcomes & Findings for A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC) (NCT NCT02998528)
NCT ID: NCT02998528
Last Updated: 2026-01-06
Results Overview
Event-free survival (EFS) is defined as the length of time from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on blinded independent central review (BICR) assessment per response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
COMPLETED
PHASE3
505 participants
From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months)
2026-01-06
Participant Flow
One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm A for baseline and efficacy analyses (analyses based on the randomized population) and is counted in Arm B (chemo) for exposure and safety analyses (based on the treated population). This participant was randomized prior to Revised Protocol 02 and is not included in the All Treated Participants from the Concurrently Randomized Arms B and C population.
Participant milestones
| Measure |
Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg
Participants received nivolumab 3 mg/kg IV over 30 minutes every 2 weeks for up to 3 doses (ie, 6 weeks of treatment; each cycle is 14 days). In Cycle 1 Day 1 only, nivolumab will be followed by a single dose of ipilimumab 1 mg/kg IV over 30 minutes.
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
|
Arm B: Platinum Doublet Chemo
Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
|
Arm C: Nivo 360 mg + Platinum Doublet Chemo
Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
|
|---|---|---|---|
|
Randomization Period
STARTED
|
113
|
213
|
179
|
|
Randomization Period
All Concurrently Randomized Participants in Arms B and C
|
0
|
179
|
179
|
|
Randomization Period
COMPLETED
|
112
|
207
|
176
|
|
Randomization Period
NOT COMPLETED
|
1
|
6
|
3
|
|
Neoadjuvant Treatment Period
STARTED
|
111
|
208
|
176
|
|
Neoadjuvant Treatment Period
All Treated Participants From Concurrently Randomized Arms B and C
|
0
|
176
|
176
|
|
Neoadjuvant Treatment Period
COMPLETED
|
101
|
177
|
165
|
|
Neoadjuvant Treatment Period
NOT COMPLETED
|
10
|
31
|
11
|
|
Systemic Adjuvant Treatment Period
STARTED
|
37
|
47
|
26
|
|
Systemic Adjuvant Treatment Period
COMPLETED
|
28
|
41
|
22
|
|
Systemic Adjuvant Treatment Period
NOT COMPLETED
|
9
|
6
|
4
|
Reasons for withdrawal
| Measure |
Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg
Participants received nivolumab 3 mg/kg IV over 30 minutes every 2 weeks for up to 3 doses (ie, 6 weeks of treatment; each cycle is 14 days). In Cycle 1 Day 1 only, nivolumab will be followed by a single dose of ipilimumab 1 mg/kg IV over 30 minutes.
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
|
Arm B: Platinum Doublet Chemo
Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
|
Arm C: Nivo 360 mg + Platinum Doublet Chemo
Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
|
|---|---|---|---|
|
Randomization Period
Adverse event unrelated to study drug
|
0
|
0
|
1
|
|
Randomization Period
Participant withdrew consent
|
0
|
3
|
0
|
|
Randomization Period
Participant no longer meets study criteria
|
1
|
3
|
2
|
|
Neoadjuvant Treatment Period
Participant request to discontinue study treatment
|
0
|
7
|
0
|
|
Neoadjuvant Treatment Period
Participant withdrew consent
|
0
|
4
|
0
|
|
Neoadjuvant Treatment Period
Participant no longer meets study criteria
|
0
|
1
|
0
|
|
Neoadjuvant Treatment Period
Disease progression
|
3
|
2
|
1
|
|
Neoadjuvant Treatment Period
Study drug toxicity
|
6
|
14
|
10
|
|
Neoadjuvant Treatment Period
Death
|
1
|
0
|
0
|
|
Neoadjuvant Treatment Period
Adverse event unrelated to study treatment
|
0
|
3
|
0
|
|
Systemic Adjuvant Treatment Period
Disease progression
|
1
|
0
|
0
|
|
Systemic Adjuvant Treatment Period
Study drug toxicity
|
4
|
5
|
1
|
|
Systemic Adjuvant Treatment Period
Adverse event unrelated to study drug
|
1
|
0
|
1
|
|
Systemic Adjuvant Treatment Period
Participant request to discontinue treatment
|
3
|
1
|
1
|
|
Systemic Adjuvant Treatment Period
Other reasons
|
0
|
0
|
1
|
Baseline Characteristics
A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg
n=113 Participants
Participants received nivolumab 3 mg/kg IV over 30 minutes every 2 weeks for up to 3 doses (ie, 6 weeks of treatment; each cycle is 14 days). In Cycle 1 Day 1 only, nivolumab will be followed by a single dose of ipilimumab 1 mg/kg IV over 30 minutes.
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
|
Arm B: Platinum Doublet Chemo
n=213 Participants
Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
|
Arm C: Nivo 360 mg + Platinum Doublet Chemo
n=179 Participants
Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
|
Total
n=505 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
< 65
|
62 Participants
n=37 Participants
|
99 Participants
n=56 Participants
|
93 Participants
n=82 Participants
|
254 Participants
n=31 Participants
|
|
Age, Customized
>= 65 AND < 75
|
40 Participants
n=37 Participants
|
96 Participants
n=56 Participants
|
75 Participants
n=82 Participants
|
211 Participants
n=31 Participants
|
|
Age, Customized
>= 75 AND < 85
|
11 Participants
n=37 Participants
|
17 Participants
n=56 Participants
|
11 Participants
n=82 Participants
|
39 Participants
n=31 Participants
|
|
Age, Customized
>= 85
|
0 Participants
n=37 Participants
|
1 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
1 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=37 Participants
|
65 Participants
n=56 Participants
|
51 Participants
n=82 Participants
|
156 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=37 Participants
|
148 Participants
n=56 Participants
|
128 Participants
n=82 Participants
|
349 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=37 Participants
|
5 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
7 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=37 Participants
|
105 Participants
n=56 Participants
|
100 Participants
n=82 Participants
|
258 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
58 Participants
n=37 Participants
|
103 Participants
n=56 Participants
|
79 Participants
n=82 Participants
|
240 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
41 Participants
n=37 Participants
|
96 Participants
n=56 Participants
|
86 Participants
n=82 Participants
|
223 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=37 Participants
|
5 Participants
n=56 Participants
|
4 Participants
n=82 Participants
|
13 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=37 Participants
|
108 Participants
n=56 Participants
|
89 Participants
n=82 Participants
|
261 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=37 Participants
|
4 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
8 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months)Population: All concurrently randomized participants in Arm C and Arm B
Event-free survival (EFS) is defined as the length of time from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on blinded independent central review (BICR) assessment per response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
Arm B: Platinum Doublet Chemo
n=179 Participants
Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
|
Arm C: Nivo 360 mg + Platinum Doublet Chemo
n=179 Participants
Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
|
|---|---|---|
|
Event-Free Survival (EFS)
|
20.80 Months
Interval 14.03 to 26.71
|
31.57 Months
Interval 30.16 to
Insufficient number of participants with events
|
PRIMARY outcome
Timeframe: From randomization up to a median of 30 months after randomization.Population: All concurrently randomized participants in Arm C and Arm B
Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR).
Outcome measures
| Measure |
Arm B: Platinum Doublet Chemo
n=179 Participants
Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
|
Arm C: Nivo 360 mg + Platinum Doublet Chemo
n=179 Participants
Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
|
|---|---|---|
|
Pathologic Complete Response (pCR) Rate
|
4 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: From randomization up to a median of 30 months after randomization.Population: All concurrently randomized participants in Arm C and Arm B
Major pathologic response (MPR) rate is defined as number of randomized participants with \</= 10% residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR). Viable tumors in situ carcinoma should not be included in MPR calculation.
Outcome measures
| Measure |
Arm B: Platinum Doublet Chemo
n=179 Participants
Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
|
Arm C: Nivo 360 mg + Platinum Doublet Chemo
n=179 Participants
Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
|
|---|---|---|
|
Major Pathologic Response (MPR) Rate
|
16 Participants
|
66 Participants
|
SECONDARY outcome
Timeframe: From randomization to the date of death (Up to approximately 93 months)Population: All concurrently randomized participants in Arm C and Arm B
Overall survival (OS) is defined as the time between the date of randomization and the date of death. OS will be censored on the last date a participant was known to be alive.
Outcome measures
| Measure |
Arm B: Platinum Doublet Chemo
n=179 Participants
Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
|
Arm C: Nivo 360 mg + Platinum Doublet Chemo
n=179 Participants
Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
|
|---|---|---|
|
Overall Survival (OS)
|
73.72 Months
Interval 47.34 to
Insufficient number of participants with events
|
NA Months
Insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From randomization to the first date of distant metastasis or the date of death in the absence of distant metastasis (Up to approximately 84 months)Population: All concurrently randomized participants in Arm C and Arm B
TTDM is defined as the time between the date of randomization and the first date of distant metastasis or the date of death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that is outside of the thorax using blinded independent central review (BICR) according to response evaluation criteria in solid tumors (RECIST) 1.1. Patients who have not developed distant metastasis or died at the time of analysis will be censored on the date of their last evaluable tumor assessment.
Outcome measures
| Measure |
Arm B: Platinum Doublet Chemo
n=179 Participants
Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
|
Arm C: Nivo 360 mg + Platinum Doublet Chemo
n=179 Participants
Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
|
|---|---|---|
|
Time to Death or Distant Metastases (TTDM)
|
36.76 Months
Interval 24.74 to 56.8
|
64.66 Months
Interval 49.02 to
Insufficient number of participants with events
|
POST_HOC outcome
Timeframe: From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 69 months)Population: All concurrently randomized participants in Arm C and Arm B
Event-free survival (EFS) is defined as the length of time from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on blinded independent central review (BICR) assessment per response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
Arm B: Platinum Doublet Chemo
n=179 Participants
Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
|
Arm C: Nivo 360 mg + Platinum Doublet Chemo
n=179 Participants
Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
|
|---|---|---|
|
Event-Free Survival (EFS)
|
21.06 Months
Interval 16.53 to 36.76
|
59.60 Months
Interval 31.57 to
Insufficient number of participants with events
|
Adverse Events
Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg
Arm B: Platinum Doublet Chemo
Arm C: Nivo 360 mg + Platinum Doublet Chemo
Serious adverse events
| Measure |
Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg
n=111 participants at risk
Participants received nivolumab 3 mg/kg IV over 30 minutes every 2 weeks for up to 3 doses (ie, 6 weeks of treatment; each cycle is 14 days). In Cycle 1 Day 1 only, nivolumab will be followed by a single dose of ipilimumab 1 mg/kg IV over 30 minutes.
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
|
Arm B: Platinum Doublet Chemo
n=208 participants at risk
Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
|
Arm C: Nivo 360 mg + Platinum Doublet Chemo
n=176 participants at risk
Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.9%
6/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.7%
3/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.96%
2/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Sickle cell anaemia with crisis
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Myocardial infarction
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Myocarditis
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Ocular myasthenia
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Colitis
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
2/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.96%
2/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Death
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Oesophageal perforation
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.3%
4/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
General physical health deterioration
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Malaise
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Syncope
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatitis
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Cellulitis
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Empyema
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Influenza
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pleural infection
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia
|
4.5%
5/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.8%
8/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.4%
6/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Post procedural infection
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Sepsis
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Septic shock
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Wound infection
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Cardiac function disturbance postoperative
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.1%
2/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Postoperative delirium
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Postoperative respiratory failure
|
1.8%
2/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Hepatic enzyme abnormal
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Transaminases increased
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.96%
2/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
1.8%
2/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
5/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.1%
2/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Second primary malignancy
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pseudoprogression
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Immune-mediated myasthenia gravis
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.96%
2/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.7%
3/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural fistula
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.96%
2/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Lung opacity
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.6%
4/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis aspiration
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.7%
3/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fistula
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.96%
2/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.1%
2/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Aortic rupture
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Arterial thrombosis
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Embolism
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.1%
2/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Hypotension
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Iliac artery occlusion
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.57%
1/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
Other adverse events
| Measure |
Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg
n=111 participants at risk
Participants received nivolumab 3 mg/kg IV over 30 minutes every 2 weeks for up to 3 doses (ie, 6 weeks of treatment; each cycle is 14 days). In Cycle 1 Day 1 only, nivolumab will be followed by a single dose of ipilimumab 1 mg/kg IV over 30 minutes.
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
|
Arm B: Platinum Doublet Chemo
n=208 participants at risk
Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
|
Arm C: Nivo 360 mg + Platinum Doublet Chemo
n=176 participants at risk
Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.1%
9/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
37.5%
78/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
35.2%
62/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.2%
17/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
10.2%
18/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.8%
39/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
32/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.2%
17/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.8%
5/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.8%
8/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.1%
9/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.2%
17/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.4%
6/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Hyperthyroidism
|
6.3%
7/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.0%
7/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Hypothyroidism
|
9.9%
11/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.1%
2/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
21.6%
24/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.8%
39/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
17.0%
30/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
21.6%
24/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
35.1%
73/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
35.8%
63/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.2%
18/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
16.3%
34/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.9%
21/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
21.6%
24/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.5%
105/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
41.5%
73/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Stomatitis
|
3.6%
4/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.8%
12/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.4%
6/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
9.0%
10/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
14.4%
30/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.4%
20/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Asthenia
|
11.7%
13/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
13.0%
27/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
10.8%
19/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Malaise
|
2.7%
3/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
26/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.3%
27/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Non-cardiac chest pain
|
3.6%
4/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.8%
12/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.0%
7/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Oedema peripheral
|
3.6%
4/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.3%
11/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.4%
6/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Pain
|
7.2%
8/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
13.9%
29/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
10.2%
18/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Pyrexia
|
16.2%
18/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
23/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.4%
20/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia
|
2.7%
3/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.7%
14/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.5%
15/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.6%
4/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.8%
8/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.1%
9/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
9.0%
10/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.9%
6/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.7%
3/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
10.8%
12/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.8%
12/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.7%
17/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Wound complication
|
3.6%
4/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.2%
15/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.0%
14/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
6.3%
7/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.7%
18/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.4%
13/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
2.7%
3/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.7%
14/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.3%
4/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood creatinine increased
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.7%
14/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.5%
15/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Neutrophil count decreased
|
6.3%
7/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
22.1%
46/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.9%
28/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Platelet count decreased
|
1.8%
2/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.7%
14/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
10.2%
18/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Weight decreased
|
2.7%
3/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.8%
12/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
10/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
White blood cell count decreased
|
3.6%
4/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
26/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
16/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.2%
18/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.5%
53/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
26.7%
47/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.4%
6/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.4%
7/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.8%
5/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.8%
2/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.3%
9/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
10/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.7%
18/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
10/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.8%
2/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
16/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.5%
8/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.8%
12/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.2%
13/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.0%
14/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.4%
6/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.8%
12/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.5%
8/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
9.0%
10/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.8%
10/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.1%
9/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Dysgeusia
|
6.3%
7/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.8%
10/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.3%
4/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
7.2%
8/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
16/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.5%
8/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.9%
4/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
10/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
7.2%
8/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.8%
8/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.3%
4/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
7.2%
8/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.2%
15/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.0%
14/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.5%
15/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
14.9%
31/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
22/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.4%
16/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.7%
18/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.5%
15/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.7%
3/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
14.4%
30/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
10.2%
18/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.4%
6/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.8%
10/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.1%
2/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.90%
1/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
13.5%
28/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.4%
20/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.3%
17/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.4%
7/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.4%
13/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.3%
17/111 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.4%
7/208 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
14.2%
25/176 • All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER