Trial Outcomes & Findings for Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Patients With Cisplatin-ineligible or Eligible Locally Advanced Squamous Cell Head and Neck Cancer (NCT NCT03349710)
NCT ID: NCT03349710
Last Updated: 2021-08-09
Results Overview
Number of Participants with an Adverse Event
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
74 participants
Primary outcome timeframe
30 Days
Results posted on
2021-08-09
Participant Flow
74 Randomized and 73 treated
Participant milestones
| Measure |
Arm A (Cohort 1)
Nivolumab + Radiotherapy
|
Arm B (Cohort 1)
Cetuximab + Radiotherapy
|
Arm C (Cohort 2)
Cisplatin + Nivolumab + Radiotherapy
|
Arm D (Cohort 2)
Cisplatin + Radiotherapy
|
|---|---|---|---|---|
|
Randomized
STARTED
|
12
|
10
|
27
|
25
|
|
Randomized
COMPLETED
|
12
|
10
|
27
|
24
|
|
Randomized
NOT COMPLETED
|
0
|
0
|
0
|
1
|
|
Treatment Period
STARTED
|
12
|
10
|
27
|
24
|
|
Treatment Period
COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period
NOT COMPLETED
|
12
|
10
|
27
|
24
|
Reasons for withdrawal
| Measure |
Arm A (Cohort 1)
Nivolumab + Radiotherapy
|
Arm B (Cohort 1)
Cetuximab + Radiotherapy
|
Arm C (Cohort 2)
Cisplatin + Nivolumab + Radiotherapy
|
Arm D (Cohort 2)
Cisplatin + Radiotherapy
|
|---|---|---|---|---|
|
Treatment Period
Death
|
0
|
0
|
1
|
0
|
|
Treatment Period
Disease Progression
|
0
|
2
|
0
|
1
|
|
Treatment Period
Study Drug Toxicity
|
1
|
0
|
1
|
1
|
|
Treatment Period
Adverse event unrelated to Study Drug
|
2
|
1
|
1
|
1
|
|
Treatment Period
admin reason by sponsor
|
0
|
7
|
0
|
19
|
|
Treatment Period
Other Reason
|
2
|
0
|
2
|
1
|
|
Treatment Period
completed
|
6
|
0
|
18
|
1
|
|
Treatment Period
participant request to discontinue
|
0
|
0
|
4
|
0
|
|
Treatment Period
participant withdrew consent
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Patients With Cisplatin-ineligible or Eligible Locally Advanced Squamous Cell Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Arm A (Cohort 1)
n=12 Participants
Nivolumab + Radiotherapy
|
Arm B (Cohort 1)
n=10 Participants
Cetuximab + Radiotherapy
|
Arm C (Cohort 2)
n=27 Participants
Cisplatin + Nivolumab + Radiotherapy
|
Arm D (Cohort 2)
n=25 Participants
Cisplatin + Radiotherapy
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
74.5 Years
STANDARD_DEVIATION 8.3 • n=99 Participants
|
74.7 Years
STANDARD_DEVIATION 6.5 • n=107 Participants
|
59.0 Years
STANDARD_DEVIATION 6.6 • n=206 Participants
|
60.8 Years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
64.2 Years
STANDARD_DEVIATION 9.7 • n=31 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
65 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
54 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
36 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 30 DaysPopulation: All Treated Participants
Number of Participants with an Adverse Event
Outcome measures
| Measure |
Arm A (Cohort 1)
n=12 Participants
Nivolumab + Radiotherapy
|
Arm B (Cohort 1)
n=10 Participants
Cetuximab + Radiotherapy
|
Arm C (Cohort 2)
n=27 Participants
Cisplatin + Nivolumab + Radiotherapy
|
Arm D (Cohort 2)
n=24 Participants
Cisplatin + Radiotherapy
|
|---|---|---|---|---|
|
Number of Participants With an Adverse Event (AE)
|
12 Participants
|
10 Participants
|
27 Participants
|
24 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: All Treated Participants
Number of Participants with an Serious Adverse Event (SAE)
Outcome measures
| Measure |
Arm A (Cohort 1)
n=12 Participants
Nivolumab + Radiotherapy
|
Arm B (Cohort 1)
n=10 Participants
Cetuximab + Radiotherapy
|
Arm C (Cohort 2)
n=27 Participants
Cisplatin + Nivolumab + Radiotherapy
|
Arm D (Cohort 2)
n=24 Participants
Cisplatin + Radiotherapy
|
|---|---|---|---|---|
|
Number of Participants With an Serious Adverse Event (SAE)
|
5 Participants
|
5 Participants
|
9 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 30 DaysPopulation: All Treated Participants
Number of Participants with an Adverse Event Leading to Discontinuation
Outcome measures
| Measure |
Arm A (Cohort 1)
n=12 Participants
Nivolumab + Radiotherapy
|
Arm B (Cohort 1)
n=10 Participants
Cetuximab + Radiotherapy
|
Arm C (Cohort 2)
n=27 Participants
Cisplatin + Nivolumab + Radiotherapy
|
Arm D (Cohort 2)
n=24 Participants
Cisplatin + Radiotherapy
|
|---|---|---|---|---|
|
Number of Participants With an Adverse Event Leading to Discontinuation
|
2 Participants
|
3 Participants
|
8 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 30 DaysPopulation: All Treated Participants Dose levels were maintained, no dose modification occurred
Number of Participants with an Adverse Event Leading to dose modification
Outcome measures
| Measure |
Arm A (Cohort 1)
n=12 Participants
Nivolumab + Radiotherapy
|
Arm B (Cohort 1)
n=10 Participants
Cetuximab + Radiotherapy
|
Arm C (Cohort 2)
n=27 Participants
Cisplatin + Nivolumab + Radiotherapy
|
Arm D (Cohort 2)
n=24 Participants
Cisplatin + Radiotherapy
|
|---|---|---|---|---|
|
Number of Participants With an Adverse Event Leading to Dose Modification
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 30 DaysPopulation: All Treated Participants
Number of Participants with select adverse events. Select Adverse events include: gastrointestinal, hepatic, hypersensitivity/infusion reaction, pulmonary, renal, or skin.
Outcome measures
| Measure |
Arm A (Cohort 1)
n=12 Participants
Nivolumab + Radiotherapy
|
Arm B (Cohort 1)
n=10 Participants
Cetuximab + Radiotherapy
|
Arm C (Cohort 2)
n=27 Participants
Cisplatin + Nivolumab + Radiotherapy
|
Arm D (Cohort 2)
n=24 Participants
Cisplatin + Radiotherapy
|
|---|---|---|---|---|
|
Number of Participants With Select Adverse Events
Gastrointestinal
|
4 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Select Adverse Events
Hepatic
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Select Adverse Events
Hypersensitivity/Infusion Reaction
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Select Adverse Events
Pulmonary
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Select Adverse Events
Renal
|
2 Participants
|
1 Participants
|
13 Participants
|
6 Participants
|
|
Number of Participants With Select Adverse Events
Skin
|
7 Participants
|
7 Participants
|
12 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: 100 daysPopulation: All Treated Participants
Number of Participants with an immune-mediated adverse event (IMAE)
Outcome measures
| Measure |
Arm A (Cohort 1)
n=12 Participants
Nivolumab + Radiotherapy
|
Arm B (Cohort 1)
n=10 Participants
Cetuximab + Radiotherapy
|
Arm C (Cohort 2)
n=27 Participants
Cisplatin + Nivolumab + Radiotherapy
|
Arm D (Cohort 2)
n=24 Participants
Cisplatin + Radiotherapy
|
|---|---|---|---|---|
|
Number of Participants With an Immune-mediated Adverse Event (IMAE)
Non-Endocrine related IMAE
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With an Immune-mediated Adverse Event (IMAE)
Endocrine related IMAE
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 100 daysPopulation: All Treated Participants - Insufficient amount of participants with IMAEs for time to onset and time to resolution
Time to onset and time to resolution of immune-related adverse events
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 100 daysPopulation: All Treated Participants
Number of Participants who experienced death
Outcome measures
| Measure |
Arm A (Cohort 1)
n=12 Participants
Nivolumab + Radiotherapy
|
Arm B (Cohort 1)
n=10 Participants
Cetuximab + Radiotherapy
|
Arm C (Cohort 2)
n=27 Participants
Cisplatin + Nivolumab + Radiotherapy
|
Arm D (Cohort 2)
n=24 Participants
Cisplatin + Radiotherapy
|
|---|---|---|---|---|
|
Number of Participants Who Experienced Death
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 30 DaysPopulation: All Treated participants with at least one on-treatment TSH measurement
Number of participants with an abnormality in specific thyroid tests
Outcome measures
| Measure |
Arm A (Cohort 1)
n=10 Participants
Nivolumab + Radiotherapy
|
Arm B (Cohort 1)
n=10 Participants
Cetuximab + Radiotherapy
|
Arm C (Cohort 2)
n=27 Participants
Cisplatin + Nivolumab + Radiotherapy
|
Arm D (Cohort 2)
n=23 Participants
Cisplatin + Radiotherapy
|
|---|---|---|---|---|
|
Number of Participants With an Abnormality in Specific Thyroid Tests
TSH > ULN
|
5 Participants
|
1 Participants
|
7 Participants
|
1 Participants
|
|
Number of Participants With an Abnormality in Specific Thyroid Tests
TSH > ULN WITH TSH <= ULN AT BASELINE
|
5 Participants
|
1 Participants
|
7 Participants
|
1 Participants
|
|
Number of Participants With an Abnormality in Specific Thyroid Tests
TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN
|
4 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With an Abnormality in Specific Thyroid Tests
TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With an Abnormality in Specific Thyroid Tests
TSH > ULN WITH FT3/FT4 TEST MISSING
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With an Abnormality in Specific Thyroid Tests
TSH < LLN
|
4 Participants
|
3 Participants
|
16 Participants
|
13 Participants
|
|
Number of Participants With an Abnormality in Specific Thyroid Tests
TSH <LLN WITH TSH >= LLN AT BASELINE
|
3 Participants
|
3 Participants
|
13 Participants
|
13 Participants
|
|
Number of Participants With an Abnormality in Specific Thyroid Tests
TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN
|
0 Participants
|
0 Participants
|
9 Participants
|
2 Participants
|
|
Number of Participants With an Abnormality in Specific Thyroid Tests
TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN
|
4 Participants
|
1 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants With an Abnormality in Specific Thyroid Tests
TSH < LLN WITH FT3/FT4 TEST MISSING
|
0 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: All Treated Participants
Number of participants with an abnormality in specific liver tests
Outcome measures
| Measure |
Arm A (Cohort 1)
n=12 Participants
Nivolumab + Radiotherapy
|
Arm B (Cohort 1)
n=10 Participants
Cetuximab + Radiotherapy
|
Arm C (Cohort 2)
n=27 Participants
Cisplatin + Nivolumab + Radiotherapy
|
Arm D (Cohort 2)
n=24 Participants
Cisplatin + Radiotherapy
|
|---|---|---|---|---|
|
Number of Participants With an Abnormality in Specific Liver Tests
ALT OR AST > 3XULN
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With an Abnormality in Specific Liver Tests
ALT OR AST> 5XULN
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With an Abnormality in Specific Liver Tests
ALT OR AST> 10XULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With an Abnormality in Specific Liver Tests
ALT OR AST > 20XULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With an Abnormality in Specific Liver Tests
TOTAL BILIRUBIN > 2XULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With an Abnormality in Specific Liver Tests
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With an Abnormality in Specific Liver Tests
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30DAYS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Arm A (Cohort 1)
Serious events: 6 serious events
Other events: 12 other events
Deaths: 2 deaths
Arm B (Cohort 1)
Serious events: 5 serious events
Other events: 10 other events
Deaths: 2 deaths
Arm C (Cohort 2)
Serious events: 10 serious events
Other events: 26 other events
Deaths: 2 deaths
Arm D (Cohort 2)
Serious events: 7 serious events
Other events: 24 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm A (Cohort 1)
n=12 participants at risk
Nivolumab + Radiotherapy
|
Arm B (Cohort 1)
n=10 participants at risk
Cetuximab + Radiotherapy
|
Arm C (Cohort 2)
n=27 participants at risk
Cisplatin + Nivolumab + Radiotherapy
|
Arm D (Cohort 2)
n=24 participants at risk
Cisplatin + Radiotherapy
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Cardiac disorders
Myocardial infarction
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
General disorders
Death
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
General disorders
Oedema peripheral
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
General disorders
Pyrexia
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Infections and infestations
Bacillus bacteraemia
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Infections and infestations
Pneumonia
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Infections and infestations
Sepsis
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Infections and infestations
Septic shock
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Investigations
Platelet count decreased
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Investigations
Transaminases increased
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
8.3%
2/24 • 101 days approximately
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal squamous cell carcinoma
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Psychiatric disorders
Delirium
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Psychiatric disorders
Psychotic disorder
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
7.4%
2/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal necrosis
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Vascular disorders
Hypotension
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
Other adverse events
| Measure |
Arm A (Cohort 1)
n=12 participants at risk
Nivolumab + Radiotherapy
|
Arm B (Cohort 1)
n=10 participants at risk
Cetuximab + Radiotherapy
|
Arm C (Cohort 2)
n=27 participants at risk
Cisplatin + Nivolumab + Radiotherapy
|
Arm D (Cohort 2)
n=24 participants at risk
Cisplatin + Radiotherapy
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
4/12 • 101 days approximately
|
30.0%
3/10 • 101 days approximately
|
44.4%
12/27 • 101 days approximately
|
33.3%
8/24 • 101 days approximately
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
7.4%
2/27 • 101 days approximately
|
16.7%
4/24 • 101 days approximately
|
|
Blood and lymphatic system disorders
Lymphopenia
|
8.3%
1/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
7.4%
2/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
11.1%
3/27 • 101 days approximately
|
20.8%
5/24 • 101 days approximately
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
7.4%
2/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Ear and labyrinth disorders
Ear pain
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
18.5%
5/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
14.8%
4/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
22.2%
6/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Eye disorders
Dry eye
|
0.00%
0/12 • 101 days approximately
|
20.0%
2/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Eye disorders
Vision blurred
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Gastrointestinal disorders
Constipation
|
33.3%
4/12 • 101 days approximately
|
20.0%
2/10 • 101 days approximately
|
48.1%
13/27 • 101 days approximately
|
50.0%
12/24 • 101 days approximately
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
4/12 • 101 days approximately
|
30.0%
3/10 • 101 days approximately
|
7.4%
2/27 • 101 days approximately
|
8.3%
2/24 • 101 days approximately
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
4/12 • 101 days approximately
|
30.0%
3/10 • 101 days approximately
|
44.4%
12/27 • 101 days approximately
|
37.5%
9/24 • 101 days approximately
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
8.3%
2/24 • 101 days approximately
|
|
Gastrointestinal disorders
Dysphagia
|
50.0%
6/12 • 101 days approximately
|
30.0%
3/10 • 101 days approximately
|
40.7%
11/27 • 101 days approximately
|
20.8%
5/24 • 101 days approximately
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.3%
1/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Gastrointestinal disorders
Glossodynia
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Gastrointestinal disorders
Lip dry
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Gastrointestinal disorders
Nausea
|
25.0%
3/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
63.0%
17/27 • 101 days approximately
|
45.8%
11/24 • 101 days approximately
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
25.9%
7/27 • 101 days approximately
|
25.0%
6/24 • 101 days approximately
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
8.3%
2/24 • 101 days approximately
|
|
Gastrointestinal disorders
Oral pain
|
8.3%
1/12 • 101 days approximately
|
20.0%
2/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Gastrointestinal disorders
Saliva altered
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
4/12 • 101 days approximately
|
40.0%
4/10 • 101 days approximately
|
37.0%
10/27 • 101 days approximately
|
29.2%
7/24 • 101 days approximately
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
22.2%
6/27 • 101 days approximately
|
33.3%
8/24 • 101 days approximately
|
|
General disorders
Asthenia
|
16.7%
2/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
7.4%
2/27 • 101 days approximately
|
8.3%
2/24 • 101 days approximately
|
|
General disorders
Fatigue
|
33.3%
4/12 • 101 days approximately
|
50.0%
5/10 • 101 days approximately
|
29.6%
8/27 • 101 days approximately
|
12.5%
3/24 • 101 days approximately
|
|
General disorders
Gait disturbance
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
General disorders
Malaise
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
8.3%
2/24 • 101 days approximately
|
|
General disorders
Mucosal inflammation
|
16.7%
2/12 • 101 days approximately
|
20.0%
2/10 • 101 days approximately
|
25.9%
7/27 • 101 days approximately
|
37.5%
9/24 • 101 days approximately
|
|
General disorders
Oedema peripheral
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
12.5%
3/24 • 101 days approximately
|
|
General disorders
Pain
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
7.4%
2/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
General disorders
Pyrexia
|
16.7%
2/12 • 101 days approximately
|
20.0%
2/10 • 101 days approximately
|
14.8%
4/27 • 101 days approximately
|
8.3%
2/24 • 101 days approximately
|
|
General disorders
Xerosis
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
8.3%
2/24 • 101 days approximately
|
|
Immune system disorders
Hypersensitivity
|
8.3%
1/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Infections and infestations
Bacterial infection
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Infections and infestations
Conjunctivitis
|
8.3%
1/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Infections and infestations
Herpes simplex
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Infections and infestations
Mucosal infection
|
16.7%
2/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
8.3%
2/24 • 101 days approximately
|
|
Infections and infestations
Oral candidiasis
|
16.7%
2/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
7.4%
2/27 • 101 days approximately
|
12.5%
3/24 • 101 days approximately
|
|
Infections and infestations
Paronychia
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Infections and infestations
Pyoderma
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Infections and infestations
Skin infection
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Infections and infestations
Wound infection
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
7.4%
2/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Injury, poisoning and procedural complications
Incision site inflammation
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/12 • 101 days approximately
|
20.0%
2/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Injury, poisoning and procedural complications
Radiation mucositis
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
33.3%
4/12 • 101 days approximately
|
50.0%
5/10 • 101 days approximately
|
29.6%
8/27 • 101 days approximately
|
50.0%
12/24 • 101 days approximately
|
|
Injury, poisoning and procedural complications
Recall phenomenon
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Injury, poisoning and procedural complications
Stoma site inflammation
|
16.7%
2/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
1/12 • 101 days approximately
|
20.0%
2/10 • 101 days approximately
|
7.4%
2/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
1/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
7.4%
2/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Investigations
Blood creatinine increased
|
16.7%
2/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
29.6%
8/27 • 101 days approximately
|
12.5%
3/24 • 101 days approximately
|
|
Investigations
Blood electrolytes abnormal
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
7.4%
2/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Investigations
Blood thyroid stimulating hormone increased
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Investigations
Blood urea increased
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Investigations
C-reactive protein increased
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
8.3%
2/24 • 101 days approximately
|
|
Investigations
Lipase increased
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
14.8%
4/27 • 101 days approximately
|
8.3%
2/24 • 101 days approximately
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
33.3%
9/27 • 101 days approximately
|
33.3%
8/24 • 101 days approximately
|
|
Investigations
Platelet count decreased
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
11.1%
3/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Investigations
Protein total decreased
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Investigations
Weight decreased
|
25.0%
3/12 • 101 days approximately
|
20.0%
2/10 • 101 days approximately
|
40.7%
11/27 • 101 days approximately
|
29.2%
7/24 • 101 days approximately
|
|
Investigations
White blood cell count decreased
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
25.9%
7/27 • 101 days approximately
|
29.2%
7/24 • 101 days approximately
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
4/12 • 101 days approximately
|
20.0%
2/10 • 101 days approximately
|
33.3%
9/27 • 101 days approximately
|
41.7%
10/24 • 101 days approximately
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
7.4%
2/27 • 101 days approximately
|
8.3%
2/24 • 101 days approximately
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.3%
1/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
14.8%
4/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
8.3%
2/24 • 101 days approximately
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
2/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
18.5%
5/27 • 101 days approximately
|
12.5%
3/24 • 101 days approximately
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/12 • 101 days approximately
|
30.0%
3/10 • 101 days approximately
|
14.8%
4/27 • 101 days approximately
|
16.7%
4/24 • 101 days approximately
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
16.7%
2/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
7.4%
2/27 • 101 days approximately
|
8.3%
2/24 • 101 days approximately
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
8.3%
1/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
7.4%
2/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
11.1%
3/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
7.4%
2/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
33.3%
4/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
7.4%
2/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
12.5%
3/24 • 101 days approximately
|
|
Nervous system disorders
Dysgeusia
|
16.7%
2/12 • 101 days approximately
|
20.0%
2/10 • 101 days approximately
|
44.4%
12/27 • 101 days approximately
|
25.0%
6/24 • 101 days approximately
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • 101 days approximately
|
20.0%
2/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
11.1%
3/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
11.1%
3/27 • 101 days approximately
|
8.3%
2/24 • 101 days approximately
|
|
Nervous system disorders
Tremor
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Psychiatric disorders
Agitation
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Psychiatric disorders
Delirium
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Psychiatric disorders
Depression
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Psychiatric disorders
Insomnia
|
25.0%
3/12 • 101 days approximately
|
20.0%
2/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
8.3%
2/24 • 101 days approximately
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
11.1%
3/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Renal and urinary disorders
Dysuria
|
8.3%
1/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Renal and urinary disorders
Urinary hesitation
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
2/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
18.5%
5/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/12 • 101 days approximately
|
20.0%
2/10 • 101 days approximately
|
7.4%
2/27 • 101 days approximately
|
8.3%
2/24 • 101 days approximately
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
11.1%
3/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
16.7%
2/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
8.3%
1/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
14.8%
4/27 • 101 days approximately
|
29.2%
7/24 • 101 days approximately
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
25.0%
3/12 • 101 days approximately
|
30.0%
3/10 • 101 days approximately
|
29.6%
8/27 • 101 days approximately
|
8.3%
2/24 • 101 days approximately
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hyposecretion
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
16.7%
2/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
20.8%
5/24 • 101 days approximately
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
7.4%
2/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
29.6%
8/27 • 101 days approximately
|
25.0%
6/24 • 101 days approximately
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/12 • 101 days approximately
|
40.0%
4/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
2/12 • 101 days approximately
|
20.0%
2/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.7%
2/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
3/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
14.8%
4/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
4/12 • 101 days approximately
|
40.0%
4/10 • 101 days approximately
|
11.1%
3/27 • 101 days approximately
|
8.3%
2/24 • 101 days approximately
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/12 • 101 days approximately
|
20.0%
2/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/12 • 101 days approximately
|
10.0%
1/10 • 101 days approximately
|
0.00%
0/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Vascular disorders
Hypertension
|
0.00%
0/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
7.4%
2/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
4.2%
1/24 • 101 days approximately
|
|
Vascular disorders
Lymphoedema
|
16.7%
2/12 • 101 days approximately
|
0.00%
0/10 • 101 days approximately
|
3.7%
1/27 • 101 days approximately
|
0.00%
0/24 • 101 days approximately
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60