Trial Outcomes & Findings for Study of Optimized Management of Nivolumab Based on Response in Patients With Advanced RCC (OMNIVORE Study) (NCT NCT03203473)
NCT ID: NCT03203473
Last Updated: 2025-04-02
Results Overview
Persistent PR or CR is defined per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 guidelines. Radiologic disease assessment was performed every 8 weeks after patients discontinued nivolumab induction therapy. At 1 year after nivolumab discontinuation, the percentage of patients with persistent PR and CR were reported (for Arm A only).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
85 participants
Primary outcome timeframe
From nivolumab discontinuation until 1 year after discontinuation with nivolumab
Results posted on
2025-04-02
Participant Flow
Eighty-five patients were enrolled between October 2017 and July 2019 at 10 centers in the United States. Two patients never initiated treatment, resulting in 83 patients for analysis.
Participant milestones
| Measure |
Overall Cohort: Initial Primary Treatment With Nivolumab (Induction Phase)
* Therapy with nivolumab (480mg IV) every cycle (1cycle=4 weeks) up to 6 cycles
* Serial imaging assessments every 8 weeks
* After confirmatory scans, patients are assigned to Arm A or Arm B.
Nivolumab: Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs
|
Arm A: Observation Arm (for Patients With Persistent Response to Induction Nivolumab)
Patients with persistent response (complete or partial response) to induction nivolumab were assigned to Arm A (Observation Arm)
* Serial imaging assessments every 8 weeks
* If progressive disease develops, salvage therapy with nivolumab (480 mg IV every 4 weeks) will be resumed.
* If there is subsequent progression on nivolumab monotherapy, ipilimumab (1 mg/kg IV every 3 weeks x 2 doses) is added.
* If progression after nivolumab + ipilimumab, therapy discontinued. If SD/PR/CR, nivolumab is continued until progression.
|
Arm B: Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Induction Nivolumab)
Patients with confirmed SD/PD to induction nivolumab were allocated to Arm B (Combination Therapy Arm).
* In combination therapy, patients received nivolumab 3 mg/kg and ipilimumab 1 mg/kg intravenously every 3 weeks for two doses.
* After then nivolumab will be continued at 480 mg IV every 4 weeks until disease progression.
* Arm B patients underwent imaging at 12 weeks and then every 8 weeks.
|
|---|---|---|---|
|
Induction Phase
STARTED
|
85
|
0
|
0
|
|
Induction Phase
COMPLETED
|
69
|
0
|
0
|
|
Induction Phase
NOT COMPLETED
|
16
|
0
|
0
|
|
Arm Allocation Phase
STARTED
|
0
|
12
|
57
|
|
Arm Allocation Phase
COMPLETED
|
0
|
0
|
0
|
|
Arm Allocation Phase
NOT COMPLETED
|
0
|
12
|
57
|
Reasons for withdrawal
| Measure |
Overall Cohort: Initial Primary Treatment With Nivolumab (Induction Phase)
* Therapy with nivolumab (480mg IV) every cycle (1cycle=4 weeks) up to 6 cycles
* Serial imaging assessments every 8 weeks
* After confirmatory scans, patients are assigned to Arm A or Arm B.
Nivolumab: Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs
|
Arm A: Observation Arm (for Patients With Persistent Response to Induction Nivolumab)
Patients with persistent response (complete or partial response) to induction nivolumab were assigned to Arm A (Observation Arm)
* Serial imaging assessments every 8 weeks
* If progressive disease develops, salvage therapy with nivolumab (480 mg IV every 4 weeks) will be resumed.
* If there is subsequent progression on nivolumab monotherapy, ipilimumab (1 mg/kg IV every 3 weeks x 2 doses) is added.
* If progression after nivolumab + ipilimumab, therapy discontinued. If SD/PR/CR, nivolumab is continued until progression.
|
Arm B: Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Induction Nivolumab)
Patients with confirmed SD/PD to induction nivolumab were allocated to Arm B (Combination Therapy Arm).
* In combination therapy, patients received nivolumab 3 mg/kg and ipilimumab 1 mg/kg intravenously every 3 weeks for two doses.
* After then nivolumab will be continued at 480 mg IV every 4 weeks until disease progression.
* Arm B patients underwent imaging at 12 weeks and then every 8 weeks.
|
|---|---|---|---|
|
Induction Phase
Never started primary treatment
|
2
|
0
|
0
|
|
Induction Phase
Withdrew from study due to progressive disease
|
7
|
0
|
0
|
|
Induction Phase
Withdrew from study due to toxicity
|
7
|
0
|
0
|
|
Arm Allocation Phase
Still on Arm A-observation
|
0
|
7
|
0
|
|
Arm Allocation Phase
started salvage therapy
|
0
|
5
|
0
|
|
Arm Allocation Phase
Disease progression
|
0
|
0
|
37
|
|
Arm Allocation Phase
Adverse Event
|
0
|
0
|
11
|
|
Arm Allocation Phase
Physician Decision
|
0
|
0
|
3
|
|
Arm Allocation Phase
Death
|
0
|
0
|
1
|
|
Arm Allocation Phase
Developed 2nd cancer
|
0
|
0
|
1
|
|
Arm Allocation Phase
Intercurrent illness
|
0
|
0
|
1
|
|
Arm Allocation Phase
Still on arm-B treatment
|
0
|
0
|
3
|
Baseline Characteristics
Study of Optimized Management of Nivolumab Based on Response in Patients With Advanced RCC (OMNIVORE Study)
Baseline characteristics by cohort
| Measure |
Overall Cohort: Initial Primary Treatment With Nivolumab (Induction Phase)
n=83 Participants
* Therapy with nivolumab (480mg IV) every cycle (1cycle=4 weeks)
* Serial imaging assessments every 8 weeks
* After confirmatory scans, patients are assigned to Arm A or Arm B.
Nivolumab: Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs
|
|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
75 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Histology
Clear Cell
|
80 Participants
n=5 Participants
|
|
Histology
Non-clear Cell
|
3 Participants
n=5 Participants
|
|
Previous systemic therapy
No
|
42 Participants
n=5 Participants
|
|
Previous systemic therapy
Yes
|
41 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From nivolumab discontinuation until 1 year after discontinuation with nivolumabPopulation: 12 patients were assigned to arm A after nivolumab induction therapy.
Persistent PR or CR is defined per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 guidelines. Radiologic disease assessment was performed every 8 weeks after patients discontinued nivolumab induction therapy. At 1 year after nivolumab discontinuation, the percentage of patients with persistent PR and CR were reported (for Arm A only).
Outcome measures
| Measure |
Arm A-Observation Arm (for Patients With Persistent Response to Induction Nivolumab)
n=12 Participants
Patients with persistent response (complete or partial response) to induction nivolumab were assigned to Arm A (Observation Arm)
* Serial imaging assessments every 8 weeks
* If progressive disease develops, therapy with nivolumab (480 mg IV every 4 weeks) will be resumed.
* If there is subsequent progression on nivolumab monotherapy, ipilimumab (1 mg/kg IV every 3 weeks x 2 doses) is added.
* If progression after nivolumab + ipilimumab, therapy discontinued. If SD/PR/CR, nivolumab is continued until progression.
|
Arm B- Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Nivolumab Induction)
Patients with confirmed SD/PD to induction nivolumab were allocated to Arm B (Combination Therapy Arm).
* In combination therapy, patients received nivolumab 3 mg/kg and ipilimumab 1 mg/kg intravenously every 3 weeks for two doses.
* After then nivolumab will be continued at 480 mg IV every 4 weeks until disease progression.
* Arm B patients underwent imaging after the first 12 weeks and then every 8 weeks..
|
|---|---|---|
|
Percentage of Subjects With Persistent Partial Response (PR) or Complete Response (CR) at 1 Year Since Nivolumab Discontinuation (Arm A Only)
|
42 percentage of participants
Interval 18.0 to 68.0
|
—
|
PRIMARY outcome
Timeframe: For arm B patients, from arm B treatment (nivolumab+ipilimumab) initiation until last imaging assessment during the treatment; assessed up to 22 months.Population: 57 patients were assigned to Arm B after nivolumab induction therapy
Response is defined per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 guideline. After initiation of ipilimumab, Arm B patients underwent imaging after the first 12 weeks and then every 8 weeks until disease progression. Best overall response during Arm B treatment were summarized with 90% confidence interval.
Outcome measures
| Measure |
Arm A-Observation Arm (for Patients With Persistent Response to Induction Nivolumab)
n=57 Participants
Patients with persistent response (complete or partial response) to induction nivolumab were assigned to Arm A (Observation Arm)
* Serial imaging assessments every 8 weeks
* If progressive disease develops, therapy with nivolumab (480 mg IV every 4 weeks) will be resumed.
* If there is subsequent progression on nivolumab monotherapy, ipilimumab (1 mg/kg IV every 3 weeks x 2 doses) is added.
* If progression after nivolumab + ipilimumab, therapy discontinued. If SD/PR/CR, nivolumab is continued until progression.
|
Arm B- Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Nivolumab Induction)
Patients with confirmed SD/PD to induction nivolumab were allocated to Arm B (Combination Therapy Arm).
* In combination therapy, patients received nivolumab 3 mg/kg and ipilimumab 1 mg/kg intravenously every 3 weeks for two doses.
* After then nivolumab will be continued at 480 mg IV every 4 weeks until disease progression.
* Arm B patients underwent imaging after the first 12 weeks and then every 8 weeks..
|
|---|---|---|
|
Percentage of Subjects With Stable or Progressive Disease (SD/PD) to Nivolumab Induction That Convert to Complete or Partial Response (CR/PR) Upon the Addition of Ipilimumab to Nivolumab (Arm B Only)
|
4 percentage of participants
Interval 1.0 to 11.0
|
—
|
SECONDARY outcome
Timeframe: After initiation of Arm B treatment, patients underwent imaging at 12 weeks and then every 8 weeks, up to 22 months.Population: 57 patients were allocated to Arm B treatment after completing nivolumab induction
Progression-free survival (PFS) for Arm B was defined as time from the start of arm B treatment until progression (by RECIST 1.1 or clinical PD) or death from any cause or censored at date of last disease evaluation for those who are alive and have not progressed. PFS distribution was estimated using the product-limit method of Kaplan-Meier, median and 95% confidence interval was reported.
Outcome measures
| Measure |
Arm A-Observation Arm (for Patients With Persistent Response to Induction Nivolumab)
n=57 Participants
Patients with persistent response (complete or partial response) to induction nivolumab were assigned to Arm A (Observation Arm)
* Serial imaging assessments every 8 weeks
* If progressive disease develops, therapy with nivolumab (480 mg IV every 4 weeks) will be resumed.
* If there is subsequent progression on nivolumab monotherapy, ipilimumab (1 mg/kg IV every 3 weeks x 2 doses) is added.
* If progression after nivolumab + ipilimumab, therapy discontinued. If SD/PR/CR, nivolumab is continued until progression.
|
Arm B- Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Nivolumab Induction)
Patients with confirmed SD/PD to induction nivolumab were allocated to Arm B (Combination Therapy Arm).
* In combination therapy, patients received nivolumab 3 mg/kg and ipilimumab 1 mg/kg intravenously every 3 weeks for two doses.
* After then nivolumab will be continued at 480 mg IV every 4 weeks until disease progression.
* Arm B patients underwent imaging after the first 12 weeks and then every 8 weeks..
|
|---|---|---|
|
Median Progression Free Survival (Arm B)
|
4.7 months
Interval 2.7 to 8.3
|
—
|
SECONDARY outcome
Timeframe: Patients were followed from initiation of Nivolumab induction until to death or date last known alive. Kaplan-Meier curve for OS assessed up to 28 months; the 18-month time point estimate for OS was reported.Population: Out of 85 patients enrolled, 83 patients received nivolumab induction treatment and were included for analysis; 2 patients who did not proceed with treatment were excluded from all analysis.
Overall survival (OS) was defined as the time from initiation of nivolumab induction until death due to any cause or censored at date of last follow-up for surviving patients. OS rate was estimated using the product-limit method of Kaplan-Meier;18-month OS rate and 95% confidence interval were reported.
Outcome measures
| Measure |
Arm A-Observation Arm (for Patients With Persistent Response to Induction Nivolumab)
n=83 Participants
Patients with persistent response (complete or partial response) to induction nivolumab were assigned to Arm A (Observation Arm)
* Serial imaging assessments every 8 weeks
* If progressive disease develops, therapy with nivolumab (480 mg IV every 4 weeks) will be resumed.
* If there is subsequent progression on nivolumab monotherapy, ipilimumab (1 mg/kg IV every 3 weeks x 2 doses) is added.
* If progression after nivolumab + ipilimumab, therapy discontinued. If SD/PR/CR, nivolumab is continued until progression.
|
Arm B- Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Nivolumab Induction)
Patients with confirmed SD/PD to induction nivolumab were allocated to Arm B (Combination Therapy Arm).
* In combination therapy, patients received nivolumab 3 mg/kg and ipilimumab 1 mg/kg intravenously every 3 weeks for two doses.
* After then nivolumab will be continued at 480 mg IV every 4 weeks until disease progression.
* Arm B patients underwent imaging after the first 12 weeks and then every 8 weeks..
|
|---|---|---|
|
18-month Overall Survival Rate From Initiation of Nivolumab Induction (Overall Cohort)
|
79 percentage of participants
Interval 67.0 to 87.0
|
—
|
SECONDARY outcome
Timeframe: For arm A, from nivolumab discontinuation until 1 year after discontinuation with nivolumabPopulation: 12 patients were allocated to arm A (observation arm) after nivolumab induction therapy.
Number and proportion of arm A patients who remained free of nivolumab treatment at 1 year since discontinuation of nivolumab induction
Outcome measures
| Measure |
Arm A-Observation Arm (for Patients With Persistent Response to Induction Nivolumab)
n=12 Participants
Patients with persistent response (complete or partial response) to induction nivolumab were assigned to Arm A (Observation Arm)
* Serial imaging assessments every 8 weeks
* If progressive disease develops, therapy with nivolumab (480 mg IV every 4 weeks) will be resumed.
* If there is subsequent progression on nivolumab monotherapy, ipilimumab (1 mg/kg IV every 3 weeks x 2 doses) is added.
* If progression after nivolumab + ipilimumab, therapy discontinued. If SD/PR/CR, nivolumab is continued until progression.
|
Arm B- Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Nivolumab Induction)
Patients with confirmed SD/PD to induction nivolumab were allocated to Arm B (Combination Therapy Arm).
* In combination therapy, patients received nivolumab 3 mg/kg and ipilimumab 1 mg/kg intravenously every 3 weeks for two doses.
* After then nivolumab will be continued at 480 mg IV every 4 weeks until disease progression.
* Arm B patients underwent imaging after the first 12 weeks and then every 8 weeks..
|
|---|---|---|
|
Percent of Subjects Who Were Free of Nivolumab Salvage Therapy at 1 Year Since Discontinuation of Nivolumab Induction (Arm A)
|
42 percentage of participants
Interval 18.0 to 68.0
|
—
|
SECONDARY outcome
Timeframe: For arm A, radiology imaging will be done every 8 weeks until disease progression. For arm B, radiology imaging will be done at 12 weeks and then every 8 weeks until disease progressionPopulation: Since the trial was designed in 2015, immune-related response has been infrequently used in VEGF/IO trials for kidney cancer. Most RCC trials have mainly focused on the traditional RECIST-based response as the primary endpoint. Therefore, the study team did not pursue immune-related response assessment and that data was not collected.
The irORR is assessed according to immune-related Response Criteria (irRC). * Immune-Related Complete Response (irCR): Complete disappearance of all tumor lesions (index and non-index together with no new measurable/unmeasurable lesions) for at least 4 weeks from the date of documentation of complete response * Decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters (SPD) of all target and all new measurable lesions in two consecutive observations not less than 4 weeks apart.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Adverse events during the nivolumab induction were measured from nivolumab initiation until 3 months following the last dose of nivolumab induction or until start of arm B treatment, assessed up to 9 months from nivolumab startPopulation: Out of 85 patients enrolled, 83 patients received nivolumab induction treatment and were included for analysis; 2 patients who did not proceed with treatment were excluded from all analysis.
Adverse event was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4. The following AE attribution was considered as treatment-related: * Definite - The AE is clearly related to the study treatment. * Probable - The AE is likely related to the study treatment. * Possible - The AE may be related to the study treatment.
Outcome measures
| Measure |
Arm A-Observation Arm (for Patients With Persistent Response to Induction Nivolumab)
n=83 Participants
Patients with persistent response (complete or partial response) to induction nivolumab were assigned to Arm A (Observation Arm)
* Serial imaging assessments every 8 weeks
* If progressive disease develops, therapy with nivolumab (480 mg IV every 4 weeks) will be resumed.
* If there is subsequent progression on nivolumab monotherapy, ipilimumab (1 mg/kg IV every 3 weeks x 2 doses) is added.
* If progression after nivolumab + ipilimumab, therapy discontinued. If SD/PR/CR, nivolumab is continued until progression.
|
Arm B- Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Nivolumab Induction)
Patients with confirmed SD/PD to induction nivolumab were allocated to Arm B (Combination Therapy Arm).
* In combination therapy, patients received nivolumab 3 mg/kg and ipilimumab 1 mg/kg intravenously every 3 weeks for two doses.
* After then nivolumab will be continued at 480 mg IV every 4 weeks until disease progression.
* Arm B patients underwent imaging after the first 12 weeks and then every 8 weeks..
|
|---|---|---|
|
Percentage of Subjects Who Experience Grade 3-4 Treatment-related Adverse Event (TRAE) During the Nivolumab Induction Therapy (Overall Cohort)
|
7 percentage of participants
Interval 3.0 to 15.0
|
—
|
SECONDARY outcome
Timeframe: For arm B, adverse events were measured from arm B treatment initiation until 3 months following the last dose of arm B treatment, assessed up to 26 months from arm B startPopulation: 57 patients had been allocated to arm B after nivolumab induction therapy
Adverse event was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4. The following AE attribution was considered as treatment-related: * Definite - The AE is clearly related to the study treatment. * Probable - The AE is likely related to the study treatment. * Possible - The AE may be related to the study treatment.
Outcome measures
| Measure |
Arm A-Observation Arm (for Patients With Persistent Response to Induction Nivolumab)
n=57 Participants
Patients with persistent response (complete or partial response) to induction nivolumab were assigned to Arm A (Observation Arm)
* Serial imaging assessments every 8 weeks
* If progressive disease develops, therapy with nivolumab (480 mg IV every 4 weeks) will be resumed.
* If there is subsequent progression on nivolumab monotherapy, ipilimumab (1 mg/kg IV every 3 weeks x 2 doses) is added.
* If progression after nivolumab + ipilimumab, therapy discontinued. If SD/PR/CR, nivolumab is continued until progression.
|
Arm B- Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Nivolumab Induction)
Patients with confirmed SD/PD to induction nivolumab were allocated to Arm B (Combination Therapy Arm).
* In combination therapy, patients received nivolumab 3 mg/kg and ipilimumab 1 mg/kg intravenously every 3 weeks for two doses.
* After then nivolumab will be continued at 480 mg IV every 4 weeks until disease progression.
* Arm B patients underwent imaging after the first 12 weeks and then every 8 weeks..
|
|---|---|---|
|
Percentage of Subjects Who Experienced Grade 3-4 Treatment Related Adverse Events (TRAE) During the Arm B Treatment (Arm B Only)
|
25 percentage of participants
Interval 14.0 to 38.0
|
—
|
SECONDARY outcome
Timeframe: From start of nivolumab induction until the discontinuation of nivolumab induction, assessed up to 7 monthsPopulation: Out of 85 patients enrolled, 83 patients received nivolumab induction treatment and were included for analysis; 2 patients who did not proceed with treatment were excluded from all analysis.
Response (PR or CR) is defined per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 guidelines. Radiologic disease assessment was performed every 8 weeks during the induction therapy with nivolumab.
Outcome measures
| Measure |
Arm A-Observation Arm (for Patients With Persistent Response to Induction Nivolumab)
n=83 Participants
Patients with persistent response (complete or partial response) to induction nivolumab were assigned to Arm A (Observation Arm)
* Serial imaging assessments every 8 weeks
* If progressive disease develops, therapy with nivolumab (480 mg IV every 4 weeks) will be resumed.
* If there is subsequent progression on nivolumab monotherapy, ipilimumab (1 mg/kg IV every 3 weeks x 2 doses) is added.
* If progression after nivolumab + ipilimumab, therapy discontinued. If SD/PR/CR, nivolumab is continued until progression.
|
Arm B- Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Nivolumab Induction)
Patients with confirmed SD/PD to induction nivolumab were allocated to Arm B (Combination Therapy Arm).
* In combination therapy, patients received nivolumab 3 mg/kg and ipilimumab 1 mg/kg intravenously every 3 weeks for two doses.
* After then nivolumab will be continued at 480 mg IV every 4 weeks until disease progression.
* Arm B patients underwent imaging after the first 12 weeks and then every 8 weeks..
|
|---|---|---|
|
Percentage of Subjects Who Had Complete or Partial Response (CR/PR) to Nivolumab Induction Therapy According to International mRCC Database Consortium (IMDC) Risk Groups.
IMDC favorable risk
|
11 percentage of participants
Interval 3.0 to 26.0
|
—
|
|
Percentage of Subjects Who Had Complete or Partial Response (CR/PR) to Nivolumab Induction Therapy According to International mRCC Database Consortium (IMDC) Risk Groups.
IMDC intermediate risk
|
13 percentage of participants
Interval 6.0 to 25.0
|
—
|
|
Percentage of Subjects Who Had Complete or Partial Response (CR/PR) to Nivolumab Induction Therapy According to International mRCC Database Consortium (IMDC) Risk Groups.
IMDC poor risk
|
9 percentage of participants
Interval 1.0 to 36.0
|
—
|
SECONDARY outcome
Timeframe: From start of nivolumab induction until the discontinuation of nivolumab induction, assessed up to 7 monthsPopulation: Out of 85 patients enrolled, 83 patients received nivolumab induction treatment and were included for analysis; 2 patients who did not proceed with treatment were excluded from all analysis.
Response (PR or CR) is defined per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 guidelines. Radiologic disease assessment was performed every 8 weeks during the induction therapy with nivolumab.
Outcome measures
| Measure |
Arm A-Observation Arm (for Patients With Persistent Response to Induction Nivolumab)
n=83 Participants
Patients with persistent response (complete or partial response) to induction nivolumab were assigned to Arm A (Observation Arm)
* Serial imaging assessments every 8 weeks
* If progressive disease develops, therapy with nivolumab (480 mg IV every 4 weeks) will be resumed.
* If there is subsequent progression on nivolumab monotherapy, ipilimumab (1 mg/kg IV every 3 weeks x 2 doses) is added.
* If progression after nivolumab + ipilimumab, therapy discontinued. If SD/PR/CR, nivolumab is continued until progression.
|
Arm B- Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Nivolumab Induction)
Patients with confirmed SD/PD to induction nivolumab were allocated to Arm B (Combination Therapy Arm).
* In combination therapy, patients received nivolumab 3 mg/kg and ipilimumab 1 mg/kg intravenously every 3 weeks for two doses.
* After then nivolumab will be continued at 480 mg IV every 4 weeks until disease progression.
* Arm B patients underwent imaging after the first 12 weeks and then every 8 weeks..
|
|---|---|---|
|
Percentage of Subjects Who Had Complete or Partial Response (CR/PR) to Nivolumab Induction Therapy According to Prior Treatment
Treatment Naive
|
12 percentage of participants
Interval 5.0 to 23.0
|
—
|
|
Percentage of Subjects Who Had Complete or Partial Response (CR/PR) to Nivolumab Induction Therapy According to Prior Treatment
Previously treated
|
12 percentage of participants
Interval 5.0 to 24.0
|
—
|
SECONDARY outcome
Timeframe: From start of nivolumab induction until the discontinuation of nivolumab induction, assessed up to 7 monthsPopulation: Given the majority (96%) of patients had clear cell histology, subgroup analysis of response by histology type was not performed.
Response (PR or CR) is defined per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 guidelines. Radiologic disease assessment was performed every 8 weeks during the induction therapy with nivolumab.
Outcome measures
Outcome data not reported
Adverse Events
Overall Cohort: Initial Primary Treatment With Nivolumab (Induction Phase)
Serious events: 6 serious events
Other events: 80 other events
Deaths: 19 deaths
Arm B: Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Induction Nivolumab)
Serious events: 14 serious events
Other events: 55 other events
Deaths: 12 deaths
Arm A: Arm A-Observation Arm (for Patients With Persistent Response to Induction Nivolumab)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Overall Cohort: Initial Primary Treatment With Nivolumab (Induction Phase)
n=83 participants at risk
* Therapy with nivolumab (480mg IV) every cycle (1cycle=4 weeks) up to 6 cycles.
* Serial imaging assessments every 8 weeks
* After confirmatory scans, patients are assigned to Arm A or Arm B.
Nivolumab: Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs
|
Arm B: Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Induction Nivolumab)
n=57 participants at risk
Patients with confirmed SD/PD to induction nivolumab were allocated to Arm B (Combination Therapy Arm).
* In combination therapy, patients received nivolumab 3 mg/kg and ipilimumab 1 mg/kg intravenously every 3 weeks for two doses.
* After then nivolumab will be continued at 480 mg IV every 4 weeks until disease progression.
* Arm B patients underwent imaging after the first 12 weeks and then every 8 weeks..
Ipilimumab: YERVOY is thought to work with the body's immune system to increase the activity of T cells and cause the body to attack cancer cells
Nivolumab: Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs
|
Arm A: Arm A-Observation Arm (for Patients With Persistent Response to Induction Nivolumab)
n=12 participants at risk
Patients with persistent response (complete or partial response) to induction nivolumab are assigned to Arm A (Observation Arm).
\- AE was not reported since this was an observation arm. If a patient resumes nivolumab therapy after progression to arm A, AE from the subsequent therapy was not counted as arm A toxicities.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Acidosis
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
3.5%
2/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Investigations
Alkaline phosphatase increased
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Investigations
Blood bilirubin increased
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
3.5%
2/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Investigations
CPK increased
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Investigations
Creatinine increased
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Eye disorders
Eye disorders - Other, specify
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
7.0%
4/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
3.5%
2/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
General disorders
Infusion related reaction
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
Other adverse events
| Measure |
Overall Cohort: Initial Primary Treatment With Nivolumab (Induction Phase)
n=83 participants at risk
* Therapy with nivolumab (480mg IV) every cycle (1cycle=4 weeks) up to 6 cycles.
* Serial imaging assessments every 8 weeks
* After confirmatory scans, patients are assigned to Arm A or Arm B.
Nivolumab: Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs
|
Arm B: Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Induction Nivolumab)
n=57 participants at risk
Patients with confirmed SD/PD to induction nivolumab were allocated to Arm B (Combination Therapy Arm).
* In combination therapy, patients received nivolumab 3 mg/kg and ipilimumab 1 mg/kg intravenously every 3 weeks for two doses.
* After then nivolumab will be continued at 480 mg IV every 4 weeks until disease progression.
* Arm B patients underwent imaging after the first 12 weeks and then every 8 weeks..
Ipilimumab: YERVOY is thought to work with the body's immune system to increase the activity of T cells and cause the body to attack cancer cells
Nivolumab: Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs
|
Arm A: Arm A-Observation Arm (for Patients With Persistent Response to Induction Nivolumab)
n=12 participants at risk
Patients with persistent response (complete or partial response) to induction nivolumab are assigned to Arm A (Observation Arm).
\- AE was not reported since this was an observation arm. If a patient resumes nivolumab therapy after progression to arm A, AE from the subsequent therapy was not counted as arm A toxicities.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.8%
4/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
5.3%
3/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
5.3%
3/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Investigations
Alanine aminotransferase increased
|
10.8%
9/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
10.5%
6/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Investigations
Alkaline phosphatase increased
|
4.8%
4/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
3.5%
2/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.8%
4/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Blood and lymphatic system disorders
Anemia
|
13.3%
11/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
3.5%
2/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Metabolism and nutrition disorders
Anorexia
|
8.4%
7/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
12.3%
7/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Psychiatric disorders
Anxiety
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
3.5%
2/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.4%
7/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
19.3%
11/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.8%
4/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Investigations
Aspartate aminotransferase increased
|
9.6%
8/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
10.5%
6/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.7%
13/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
5.3%
3/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Gastrointestinal disorders
Bloating
|
3.6%
3/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
3.5%
2/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Investigations
Blood bilirubin increased
|
3.6%
3/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Eye disorders
Blurred vision
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Infections and infestations
Bronchial infection
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Injury, poisoning and procedural complications
Bruising
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Investigations
CD4 lymphocytes decreased
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
General disorders
Chills
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
5.3%
3/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Psychiatric disorders
Confusion
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Gastrointestinal disorders
Constipation
|
8.4%
7/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
7.0%
4/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.5%
12/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
15.8%
9/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Investigations
Creatinine increased
|
6.0%
5/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
3.5%
2/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Psychiatric disorders
Depression
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Gastrointestinal disorders
Diarrhea
|
19.3%
16/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
17.5%
10/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Nervous system disorders
Dizziness
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
5.3%
3/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Eye disorders
Dry eye
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Gastrointestinal disorders
Dry mouth
|
6.0%
5/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
3.5%
2/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.8%
4/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
3.5%
2/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Nervous system disorders
Dysgeusia
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Gastrointestinal disorders
Dysphagia
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.7%
13/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
3.5%
2/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
General disorders
Edema face
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
General disorders
Edema limbs
|
7.2%
6/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
3.5%
2/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
General disorders
Edema trunk
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
3.5%
2/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Eye disorders
Eye disorders - Other, specify
|
3.6%
3/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Nervous system disorders
Facial muscle weakness
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Nervous system disorders
Facial nerve disorder
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Injury, poisoning and procedural complications
Fall
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
General disorders
Fatigue
|
45.8%
38/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
26.3%
15/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
General disorders
Fever
|
6.0%
5/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
3.5%
2/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
3.5%
2/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Eye disorders
Flashing lights
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
General disorders
Flu like symptoms
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
3.5%
2/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Injury, poisoning and procedural complications
Fracture
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
General disorders
Gait disturbance
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
4.8%
4/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
5.3%
3/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Nervous system disorders
Headache
|
8.4%
7/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
19.3%
11/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Cardiac disorders
Heart failure
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Vascular disorders
Hematoma
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Renal and urinary disorders
Hematuria
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Vascular disorders
Hot flashes
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
3.5%
2/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.6%
3/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.0%
10/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
17.5%
10/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.2%
6/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
8.8%
5/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Vascular disorders
Hypertension
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Endocrine disorders
Hyperthyroidism
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
5.3%
3/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
5.3%
3/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.4%
7/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
10.5%
6/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Endocrine disorders
Hypothyroidism
|
3.6%
3/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
8.8%
5/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
3.5%
2/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
General disorders
Infusion related reaction
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
5/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
10.5%
6/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Psychiatric disorders
Insomnia
|
6.0%
5/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
3.5%
2/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Nervous system disorders
Intracranial hemorrhage
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukemia secondary to oncology chemotherapy
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
3.5%
2/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
3.5%
2/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Investigations
Lipase increased
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
General disorders
Localized edema
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Infections and infestations
Lung infection
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
5.3%
3/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Vascular disorders
Lymphedema
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Investigations
Lymphocyte count decreased
|
3.6%
3/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Cardiac disorders
Mitral valve disease
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Gastrointestinal disorders
Mucositis oral
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
3.5%
2/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
3.5%
2/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
7.0%
4/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.8%
4/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
3.5%
2/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Gastrointestinal disorders
Nausea
|
15.7%
13/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
19.3%
11/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
5.3%
3/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Nervous system disorders
Neuralgia
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Investigations
Neutrophil count decreased
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
3.5%
2/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
General disorders
Non-cardiac chest pain
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
General disorders
Pain
|
4.8%
4/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
12.3%
7/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.3%
11/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
8.8%
5/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Infections and infestations
Papulopustular rash
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
3.5%
2/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Psychiatric disorders
Personality change
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Investigations
Platelet count decreased
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.6%
3/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
3.5%
2/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.6%
3/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.7%
13/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
19.3%
11/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.0%
5/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.6%
8/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
12.3%
7/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
5.3%
3/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
3.6%
3/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Gastrointestinal disorders
Retroperitoneal hemorrhage
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Nervous system disorders
Seizure
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Cardiac disorders
Sinus tachycardia
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Infections and infestations
Sinusitis
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
10.8%
9/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
8.8%
5/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Infections and infestations
Skin infection
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
7.0%
4/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Nervous system disorders
Syncope
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
3.5%
2/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Vascular disorders
Thromboembolic event
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
5.3%
3/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Gastrointestinal disorders
Toothache
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal fistula
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Infections and infestations
Upper respiratory infection
|
6.0%
5/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
7.0%
4/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Renal and urinary disorders
Urinary frequency
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
5.3%
3/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Renal and urinary disorders
Urinary tract pain
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Renal and urinary disorders
Urinary urgency
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Reproductive system and breast disorders
Uterine hemorrhage
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Infections and infestations
Vaginal infection
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Investigations
Weight gain
|
6.0%
5/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Investigations
Weight loss
|
2.4%
2/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
8.8%
5/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.2%
1/83 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
1.8%
1/57 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
0.00%
0/12 • Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place