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An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors (CheckMate358)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02488759
Recruitment Status : Active, not recruiting
First Posted : July 2, 2015
Results First Posted : April 12, 2022
Last Update Posted : July 7, 2022
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Various Advanced Cancer
Interventions Drug: Nivolumab
Drug: Ipilimumab
Drug: Relatlimab
Drug: Daratumumab
Enrollment 578
Recruitment Details  
Pre-assignment Details 578 participants treated
Arm/Group Title Metastatic Monotherapy Metastatic Combo A Metastatic Combo B Metastatic Combo C Metastatic Combo D Neoadjuvant
Hide Arm/Group Description Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 month, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
Period Title: Overall Study
Started [1] 113 195 133 8 6 123
Completed [2] 2 0 2 0 0 0
Not Completed 111 195 131 8 6 123
Reason Not Completed
Disease progression             74             110             62             7             4             2
Study drug toxicity             11             33             31             0             0             2
Adverse event unrelated to study drug             9             11             7             0             1             0
Participant request to discontinue study treatment             7             8             4             0             0             0
Withdrawal by Subject             2             0             3             0             0             2
Lost to Follow-up             0             1             2             0             0             0
Maximum clinical benefit             3             0             1             0             0             0
Completed treatment             0             0             0             0             0             116
Other reasons             5             32             21             1             1             1
[1]
Started = treated
[2]
Completed = continuing in the treatment period
Arm/Group Title Metastatic Monotherapy Metastatic Combo A Metastatic Combo B Metastatic Combo C Metastatic Combo D Neoadjuvant Total
Hide Arm/Group Description Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 month, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15 Total of all reporting groups
Overall Number of Baseline Participants 113 195 133 8 6 123 578
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 113 participants 195 participants 133 participants 8 participants 6 participants 123 participants 578 participants
57.4  (13.5) 57.5  (13.2) 48.2  (12.3) 59.0  (7.6) 66.5  (15.3) 62.0  (12.7) 58.4  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 195 participants 133 participants 8 participants 6 participants 123 participants 578 participants
Female
39
  34.5%
85
  43.6%
129
  97.0%
1
  12.5%
3
  50.0%
59
  48.0%
316
  54.7%
Male
74
  65.5%
110
  56.4%
4
   3.0%
7
  87.5%
3
  50.0%
64
  52.0%
262
  45.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 195 participants 133 participants 8 participants 6 participants 123 participants 578 participants
American Indian or Alaska Native
2
   1.8%
0
   0.0%
2
   1.5%
0
   0.0%
0
   0.0%
2
   1.6%
6
   1.0%
Asian
14
  12.4%
31
  15.9%
10
   7.5%
0
   0.0%
0
   0.0%
1
   0.8%
56
   9.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   2.7%
6
   3.1%
5
   3.8%
0
   0.0%
0
   0.0%
3
   2.4%
17
   2.9%
White
86
  76.1%
147
  75.4%
115
  86.5%
8
 100.0%
6
 100.0%
113
  91.9%
475
  82.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
8
   7.1%
11
   5.6%
1
   0.8%
0
   0.0%
0
   0.0%
4
   3.3%
24
   4.2%
1.Primary Outcome
Title Neoadjuvant: Number of Participants With Drug-Related Select Adverse Events (AEs)
Hide Description Number of participants with any grade of drug-related select adverse events (AEs) including endocrine, gastrointestinal, hepatic, pulmonary, renal, skin, and hypersensitivity AEs in Neoadjuvant cohort
Time Frame From first dose to 30 days post last dose (Up to 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in the neoadjuvant cohort
Arm/Group Title Neoadjuvant
Hide Arm/Group Description:
Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
Overall Number of Participants Analyzed 123
Measure Type: Count of Participants
Unit of Measure: Participants
Endocrine AEs
3
   2.4%
Gastrointestinal AEs
4
   3.3%
Hepatic AEs
3
   2.4%
Pulmonary AEs
0
   0.0%
Renal AEs
0
   0.0%
Skin AEs
9
   7.3%
Hypersensitivity/Infusion Reaction AEs
5
   4.1%
2.Primary Outcome
Title Neoadjuvant: Number of Participants With Drug-Related Serious Adverse Events (SAEs)
Hide Description Number of participants with any grade of drug-related serious adverse events (SAEs) in Neoadjuvant cohort
Time Frame From first dose to 30 days post last dose (Up to 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in the neoadjuvant cohort
Arm/Group Title Neoadjuvant
Hide Arm/Group Description:
Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
Overall Number of Participants Analyzed 123
Measure Type: Count of Participants
Unit of Measure: Participants
6
   4.9%
3.Primary Outcome
Title Neoadjuvant: Rate of Surgery Delay
Hide Description Rate of surgery delay is defined as the percentage of participants in the neoadjuvant cohort with surgery delayed > 4 weeks from the planned surgery date or planned start date for chemoradiation due to a drug-related adverse event
Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All tumor reduction evaluable participants in the neoadjuvant cohort
Arm/Group Title Neoadjuvant
Hide Arm/Group Description:
Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
Overall Number of Participants Analyzed 111
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
1.8
(0.2 to 6.4)
4.Primary Outcome
Title Metastatic: Investigator-Assessed Objective Response Rate (ORR)
Hide Description

Objective response rate (ORR) is defined as the the number of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) divided by the number of treated participants using RECIST 1.1 criteria. An ORR in excess of 10% will be considered of clinical interest, and an ORR of 25% or greater will be considered of strong clinical interest.

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Participants with the following diseases will be assessed:

  1. EBV positive related gastric cancer;
  2. HPV positive SCCHN;
  3. Other anogenital HPV associated cancers;
  4. GYN (Cervical, Vaginal, Vulvar) carcinoma;
  5. Merkel cell carcinoma (MCC);
  6. Nasopharyngeal carcinoma (NPC)
Time Frame Up to 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in the metastatic cohorts
Arm/Group Title Metastatic Monotherapy Metastatic Combo A Metastatic Combo B Metastatic Combo C Metastatic Combo D
Hide Arm/Group Description:
Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 month, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Overall Number of Participants Analyzed 113 195 133 8 6
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
EBV positive related gastric cancer Number Analyzed 14 participants 0 participants 0 participants 0 participants 0 participants
14.3
(1.8 to 42.8)
HPV positive SCCHN Number Analyzed 26 participants 42 participants 0 participants 8 participants 0 participants
11.5
(2.4 to 30.2)
31.0
(17.6 to 47.1)
0
(0.0 to 36.9)
Other anogenital HPV associated cancers Number Analyzed 0 participants 23 participants 21 participants 0 participants 0 participants
34.8
(16.4 to 57.3)
28.6
(11.3 to 52.2)
SCCHN I-O naive Number Analyzed 0 participants 0 participants 0 participants 0 participants 6 participants
16.7
(0.4 to 64.1)
Cervical Number Analyzed 19 participants 45 participants 45 participants 0 participants 0 participants
26.3
(9.1 to 51.2)
31.1
(18.2 to 46.6)
40.0
(25.7 to 55.7)
Cervical first line Number Analyzed 0 participants 0 participants 44 participants 0 participants 0 participants
36.4
(22.4 to 52.2)
Cervical second line Number Analyzed 0 participants 0 participants 23 participants 0 participants 0 participants
39.1
(19.7 to 61.5)
Vaginal/Vulvar Number Analyzed 5 participants 0 participants 0 participants 0 participants 0 participants
20.0
(0.5 to 71.6)
MCC Number Analyzed 25 participants 43 participants 0 participants 0 participants 0 participants
64.0
(42.5 to 82.0)
58.1
(42.1 to 73.0)
NPC Number Analyzed 24 participants 42 participants 0 participants 0 participants 0 participants
16.7
(4.7 to 37.4)
26.2
(13.9 to 42.0)
5.Secondary Outcome
Title Metastatic: Investigator-Assessed Duration of Response (DoR)
Hide Description

Duration of response (DoR) is defined as the time from first confirmed response (complete response or partial response) to the date of the initial objectively documented tumor progression as determined per investigator assessment using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants with the following diseases will be assessed:

  1. EBV positive related gastric cancer;
  2. HPV positive SCCHN;
  3. Other anogenital HPV associated cancers;
  4. GYN (Cervical, Vaginal, Vulvar) carcinoma;
  5. Merkel cell carcinoma (MCC);
  6. Nasopharyngeal carcinoma (NPC)
Time Frame Up to 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
All responders in the metastatic cohorts
Arm/Group Title Metastatic Monotherapy Metastatic Combo A Metastatic Combo B Metastatic Combo C Metastatic Combo D
Hide Arm/Group Description:
Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 month, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Overall Number of Participants Analyzed 113 195 133 8 6
Median (95% Confidence Interval)
Unit of Measure: Months
EBV positive related gastric cancer Number Analyzed 2 participants 0 participants 0 participants 0 participants 0 participants
NA [1] 
(NA to NA)
HPV positive SCCHN Number Analyzed 3 participants 13 participants 0 participants 0 participants 0 participants
NA [2] 
(24.90 to NA)
34.46 [3] 
(10.45 to NA)
Other anogenital HPV associated cancers Number Analyzed 0 participants 8 participants 6 participants 0 participants 0 participants
18.23
(3.68 to 27.93)
4.65 [3] 
(3.58 to NA)
SCCHN I-O naive Number Analyzed 0 participants 0 participants 0 participants 0 participants 1 participants
NA [1] 
(NA to NA)
Cervical Number Analyzed 5 participants 14 participants 18 participants 0 participants 0 participants
NA [2] 
(35.29 to NA)
24.44 [3] 
(8.67 to NA)
34.07 [3] 
(15.28 to NA)
Cervical first line Number Analyzed 0 participants 0 participants 16 participants 0 participants 0 participants
14.13 [3] 
(5.98 to NA)
Cervical second line Number Analyzed 0 participants 0 participants 9 participants 0 participants 0 participants
NA [2] 
(2.20 to NA)
Vaginal/Vulvar Number Analyzed 1 participants 0 participants 0 participants 0 participants 0 participants
4.96 [4] 
(NA to NA)
MCC Number Analyzed 16 participants 25 participants 0 participants 0 participants 0 participants
60.62 [3] 
(16.72 to NA)
25.86 [3] 
(12.22 to NA)
NPC Number Analyzed 4 participants 11 participants 0 participants 0 participants 0 participants
9.46 [3] 
(3.68 to NA)
21.95 [3] 
(5.55 to NA)
[1]
Median not reached as insufficient progression events among responders
[2]
Median not reached as insufficient progression events among responders and Upper limit not calculable as upper CI bound does not cross 50% threshold
[3]
Upper limit not calculable as upper CI bound does not cross 50% threshold
[4]
Lower limit and Upper limit not calculable as upper CI bound does not cross 50% threshold
6.Secondary Outcome
Title Metastatic: Overall Survival (OS)
Hide Description

Overall survival (OS) is defined as the time from first dosing date to the date of death. A participant who has not died will be censored at last known date alive. Participants with the following diseases will be assessed:

  1. EBV positive related gastric cancer;
  2. HPV positive SCCHN;
  3. Other anogenital HPV associated cancers;
  4. GYN (Cervical, Vaginal, Vulvar) carcinoma;
  5. Merkel cell carcinoma (MCC);
  6. Nasopharyngeal carcinoma (NPC)
Time Frame Up to 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in the metastatic cohorts
Arm/Group Title Metastatic Monotherapy Metastatic Combo A Metastatic Combo B Metastatic Combo C Metastatic Combo D
Hide Arm/Group Description:
Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 month, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Overall Number of Participants Analyzed 113 195 133 8 6
Median (95% Confidence Interval)
Unit of Measure: Months
EBV positive related gastric cancer Number Analyzed 14 participants 0 participants 0 participants 0 participants 0 participants
9.99
(3.09 to 30.13)
HPV positive SCCHN Number Analyzed 26 participants 42 participants 0 participants 8 participants 0 participants
20.44
(13.90 to 64.59)
17.15
(9.49 to 26.91)
8.84
(2.50 to 35.06)
Other anogenital HPV associated cancers Number Analyzed 0 participants 23 participants 21 participants 0 participants 0 participants
12.12
(6.83 to 29.54)
14.06
(9.92 to 30.59)
SCCHN I-O naive Number Analyzed 0 participants 0 participants 0 participants 0 participants 6 participants
4.21 [1] 
(1.68 to NA)
Cervical Number Analyzed 19 participants 45 participants 45 participants 0 participants 0 participants
21.55
(8.31 to 46.92)
15.24
(9.03 to 36.21)
24.74
(16.59 to 49.12)
Cervical first line Number Analyzed 0 participants 0 participants 44 participants 0 participants 0 participants
20.93 [1] 
(12.12 to NA)
Cervical second line Number Analyzed 0 participants 0 participants 23 participants 0 participants 0 participants
13.31 [1] 
(4.37 to NA)
Vaginal/Vulvar Number Analyzed 5 participants 0 participants 0 participants 0 participants 0 participants
10.28
(3.88 to 23.72)
MCC Number Analyzed 25 participants 43 participants 0 participants 0 participants 0 participants
NA [2] 
(23.26 to NA)
29.83 [1] 
(8.51 to NA)
NPC Number Analyzed 24 participants 42 participants 0 participants 0 participants 0 participants
22.74
(12.62 to 35.29)
23.56
(16.82 to 37.68)
[1]
Upper limit not calculable as upper CI bound does not cross 50% threshold
[2]
Median not reached as insufficient progression events among responders and Upper limit not calculable as upper CI bound does not cross 50% threshold
7.Secondary Outcome
Title Metastatic: Investigator-Assessed Progression-Free Survival (PFS)
Hide Description

Investigator-assessed progression free survival (PFS) is defined as the time from first dosing date to the date of the first documented tumor progression, as determined by investigators (per RECIST 1.1), or death due to any. Participants with the following diseases will be assessed:

  1. EBV positive related gastric cancer;
  2. HPV positive SCCHN;
  3. Other anogenital HPV associated cancers;
  4. GYN (Cervical, Vaginal, Vulvar) carcinoma;
  5. Merkel cell carcinoma (MCC);
  6. Nasopharyngeal carcinoma (NPC)
Time Frame Up to 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in the metastatic cohorts
Arm/Group Title Metastatic Monotherapy Metastatic Combo A Metastatic Combo B Metastatic Combo C Metastatic Combo D
Hide Arm/Group Description:
Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 month, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Overall Number of Participants Analyzed 113 195 133 8 6
Median (95% Confidence Interval)
Unit of Measure: Months
EBV positive related gastric cancer Number Analyzed 14 participants 0 participants 0 participants 0 participants 0 participants
2.94
(1.05 to 3.75)
HPV positive SCCHN Number Analyzed 26 participants 42 participants 0 participants 8 participants 0 participants
3.25
(1.84 to 6.93)
3.71
(1.77 to 7.39)
3.81
(1.77 to 7.39)
Other anogenital HPV associated cancers Number Analyzed 0 participants 23 participants 21 participants 0 participants 0 participants
4.63
(1.94 to 14.29)
3.58
(2.04 to 7.49)
SCCHN I-O naive Number Analyzed 0 participants 0 participants 0 participants 0 participants 6 participants
1.81 [1] 
(1.08 to NA)
Cervical Number Analyzed 19 participants 45 participants 45 participants 0 participants 0 participants
5.09
(1.87 to 9.07)
3.75
(2.07 to 10.28)
7.20
(3.75 to 17.25)
Cervical first line Number Analyzed 0 participants 0 participants 44 participants 0 participants 0 participants
5.45
(2.92 to 10.45)
Cervical second line Number Analyzed 0 participants 0 participants 23 participants 0 participants 0 participants
3.52
(2.30 to 14.29)
Vaginal/Vulvar Number Analyzed 5 participants 0 participants 0 participants 0 participants 0 participants
3.75
(1.22 to 8.15)
MCC Number Analyzed 25 participants 43 participants 0 participants 0 participants 0 participants
21.32
(9.20 to 62.52)
9.49
(3.71 to 24.34)
NPC Number Analyzed 24 participants 42 participants 0 participants 0 participants 0 participants
1.94
(1.54 to 3.58)
4.40
(2.37 to 9.03)
[1]
Upper limit not calculable as upper CI bound does not cross 50% threshold
Time Frame From first dose to 100 days post last dose (Up to 72 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Metastatic Monotherapy Metastatic Combo A Metastatic Combo B Metastatic Combo C Metastatic Combo D Neoadjuvant
Hide Arm/Group Description Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 month, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first Nivolumab IV over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
All-Cause Mortality
Metastatic Monotherapy Metastatic Combo A Metastatic Combo B Metastatic Combo C Metastatic Combo D Neoadjuvant
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   76/113 (67.26%)   125/195 (64.10%)   76/133 (57.14%)   6/8 (75.00%)   4/6 (66.67%)   33/123 (26.83%) 
Hide Serious Adverse Events
Metastatic Monotherapy Metastatic Combo A Metastatic Combo B Metastatic Combo C Metastatic Combo D Neoadjuvant
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   58/113 (51.33%)   129/195 (66.15%)   99/133 (74.44%)   5/8 (62.50%)   5/6 (83.33%)   40/123 (32.52%) 
Blood and lymphatic system disorders             
Anaemia  1  1/113 (0.88%)  1/195 (0.51%)  5/133 (3.76%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Febrile neutropenia  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  2/123 (1.63%) 
Iron deficiency anaemia  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Lymph node pain  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Cardiac disorders             
Acute coronary syndrome  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Acute myocardial infarction  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Angina pectoris  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  1/8 (12.50%)  0/6 (0.00%)  0/123 (0.00%) 
Atrial fibrillation  1  1/113 (0.88%)  2/195 (1.03%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Autoimmune pericarditis  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Cardiac arrest  1  0/113 (0.00%)  0/195 (0.00%)  2/133 (1.50%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Cardiac failure  1  2/113 (1.77%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Cardiac tamponade  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Coronary artery disease  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Mitral valve incompetence  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Myocarditis  1  0/113 (0.00%)  1/195 (0.51%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Pericardial effusion  1  0/113 (0.00%)  2/195 (1.03%)  2/133 (1.50%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Sinus bradycardia  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Supraventricular tachycardia  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Endocrine disorders             
Adrenal insufficiency  1  1/113 (0.88%)  4/195 (2.05%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Glucocorticoid deficiency  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Hyperthyroidism  1  0/113 (0.00%)  1/195 (0.51%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Hypophysitis  1  0/113 (0.00%)  0/195 (0.00%)  3/133 (2.26%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Hypothyroidism  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Inappropriate antidiuretic hormone secretion  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Thyroid disorder  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Eye disorders             
Uveitis  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Gastrointestinal disorders             
Abdominal distension  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Abdominal pain  1  0/113 (0.00%)  3/195 (1.54%)  2/133 (1.50%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Abdominal pain lower  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Anal fistula  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Anorectal disorder  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Ascites  1  1/113 (0.88%)  1/195 (0.51%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Colitis  1  1/113 (0.88%)  3/195 (1.54%)  11/133 (8.27%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Constipation  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Diarrhoea  1  1/113 (0.88%)  9/195 (4.62%)  4/133 (3.01%)  0/8 (0.00%)  0/6 (0.00%)  2/123 (1.63%) 
Dysphagia  1  1/113 (0.88%)  3/195 (1.54%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Gastritis  1  0/113 (0.00%)  1/195 (0.51%)  2/133 (1.50%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Gastrointestinal haemorrhage  1  1/113 (0.88%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Gastrointestinal motility disorder  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Glossodynia  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Ileus  1  0/113 (0.00%)  0/195 (0.00%)  2/133 (1.50%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Immune-mediated enterocolitis  1  1/113 (0.88%)  1/195 (0.51%)  3/133 (2.26%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Immune-mediated pancreatitis  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Intestinal obstruction  1  1/113 (0.88%)  0/195 (0.00%)  7/133 (5.26%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Intestinal perforation  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Large intestinal obstruction  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Mouth haemorrhage  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  3/123 (2.44%) 
Nausea  1  0/113 (0.00%)  2/195 (1.03%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Oesophageal motility disorder  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Oesophagitis  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Pancreatitis  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Proctalgia  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Small intestinal obstruction  1  2/113 (1.77%)  1/195 (0.51%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Stomatitis  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Vomiting  1  0/113 (0.00%)  4/195 (2.05%)  2/133 (1.50%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
General disorders             
Asthenia  1  1/113 (0.88%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Chills  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Complication associated with device  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Death  1  0/113 (0.00%)  2/195 (1.03%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Facial pain  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Fatigue  1  0/113 (0.00%)  1/195 (0.51%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
General physical health deterioration  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Hyperthermia  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Malaise  1  2/113 (1.77%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Mucosal inflammation  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  3/123 (2.44%) 
Multiple organ dysfunction syndrome  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Non-cardiac chest pain  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Oedema peripheral  1  0/113 (0.00%)  2/195 (1.03%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Pain  1  1/113 (0.88%)  2/195 (1.03%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Performance status decreased  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Pyrexia  1  3/113 (2.65%)  5/195 (2.56%)  7/133 (5.26%)  0/8 (0.00%)  0/6 (0.00%)  2/123 (1.63%) 
Sudden death  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Systemic inflammatory response syndrome  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Hepatobiliary disorders             
Autoimmune cholangitis  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Autoimmune hepatitis  1  0/113 (0.00%)  1/195 (0.51%)  3/133 (2.26%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Bile duct stenosis  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Biliary obstruction  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Biliary tract disorder  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Cholecystitis  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Gallbladder rupture  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Hepatic cytolysis  1  2/113 (1.77%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Hepatic function abnormal  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Hepatitis  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Hepatitis toxic  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Hepatotoxicity  1  0/113 (0.00%)  0/195 (0.00%)  6/133 (4.51%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Hypertransaminasaemia  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Immune system disorders             
Anaphylactic reaction  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Hypersensitivity  1  0/113 (0.00%)  1/195 (0.51%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Sarcoidosis  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Infections and infestations             
Abscess neck  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Arthritis bacterial  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Bacteraemia  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
COVID-19  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Catheter site infection  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Cellulitis  1  1/113 (0.88%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Clostridial sepsis  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Clostridium difficile colitis  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Device related infection  1  2/113 (1.77%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Device related sepsis  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Encephalitis  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Gastroenteritis  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Gastroenteritis bacterial  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Kidney infection  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Large intestine infection  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  1/6 (16.67%)  0/123 (0.00%) 
Localised infection  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Lower respiratory tract infection  1  0/113 (0.00%)  3/195 (1.54%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Meningitis  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Meningitis aseptic  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Osteomyelitis  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Otitis media  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Periorbital infection  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Pneumonia  1  2/113 (1.77%)  3/195 (1.54%)  1/133 (0.75%)  0/8 (0.00%)  1/6 (16.67%)  0/123 (0.00%) 
Pneumonia aspiration  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Pneumonia bacterial  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Post procedural infection  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Postoperative wound infection  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Pulmonary sepsis  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Pyelonephritis  1  1/113 (0.88%)  1/195 (0.51%)  4/133 (3.01%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Pyelonephritis acute  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Respiratory tract infection  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  1/6 (16.67%)  0/123 (0.00%) 
Sepsis  1  3/113 (2.65%)  6/195 (3.08%)  4/133 (3.01%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Septic shock  1  0/113 (0.00%)  1/195 (0.51%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Sinusitis  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Skin infection  1  0/113 (0.00%)  1/195 (0.51%)  2/133 (1.50%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Soft tissue infection  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Stoma site infection  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Tuberculosis  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Upper respiratory tract infection  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Urinary tract infection  1  3/113 (2.65%)  11/195 (5.64%)  7/133 (5.26%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Urosepsis  1  0/113 (0.00%)  1/195 (0.51%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Vascular device infection  1  1/113 (0.88%)  2/195 (1.03%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Injury, poisoning and procedural complications             
Fracture  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Hip fracture  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Post procedural fistula  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Post procedural haemorrhage  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Postoperative wound complication  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Procedural pain  1  0/113 (0.00%)  0/195 (0.00%)  2/133 (1.50%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Recall phenomenon  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Spinal compression fracture  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Subdural haematoma  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Transfusion reaction  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Investigations             
Alanine aminotransferase increased  1  0/113 (0.00%)  1/195 (0.51%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Aspartate aminotransferase increased  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Blood bilirubin increased  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Blood creatinine increased  1  0/113 (0.00%)  1/195 (0.51%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Blood magnesium decreased  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Blood pressure decreased  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Cytomegalovirus test positive  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
General physical condition abnormal  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
International normalised ratio increased  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Lipase increased  1  0/113 (0.00%)  2/195 (1.03%)  2/133 (1.50%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Liver function test increased  1  0/113 (0.00%)  1/195 (0.51%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Respiratory syncytial virus test positive  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Transaminases increased  1  0/113 (0.00%)  0/195 (0.00%)  2/133 (1.50%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Troponin I increased  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Troponin increased  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Urine output decreased  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Metabolism and nutrition disorders             
Decreased appetite  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Dehydration  1  1/113 (0.88%)  4/195 (2.05%)  2/133 (1.50%)  0/8 (0.00%)  0/6 (0.00%)  3/123 (2.44%) 
Diabetic ketoacidosis  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Hypercalcaemia  1  1/113 (0.88%)  4/195 (2.05%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Hyperglycaemia  1  0/113 (0.00%)  1/195 (0.51%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Hyperkalaemia  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Hypokalaemia  1  0/113 (0.00%)  2/195 (1.03%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Hyponatraemia  1  0/113 (0.00%)  2/195 (1.03%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Hypophagia  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Type 1 diabetes mellitus  1  0/113 (0.00%)  2/195 (1.03%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Musculoskeletal and connective tissue disorders             
Arthralgia  1  0/113 (0.00%)  2/195 (1.03%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Back pain  1  1/113 (0.88%)  2/195 (1.03%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Fistula  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Flank pain  1  0/113 (0.00%)  2/195 (1.03%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Intervertebral disc protrusion  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Muscular weakness  1  0/113 (0.00%)  2/195 (1.03%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Myositis  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Pain in extremity  1  0/113 (0.00%)  4/195 (2.05%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Pathological fracture  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  1/8 (12.50%)  0/6 (0.00%)  0/123 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Acute myeloid leukaemia  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Extranodal marginal zone B-cell lymphoma (MALT type)  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Infected neoplasm  1  0/113 (0.00%)  1/195 (0.51%)  2/133 (1.50%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Lung adenocarcinoma  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Lung neoplasm malignant  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Malignant melanoma  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Malignant neoplasm progression  1  24/113 (21.24%)  39/195 (20.00%)  20/133 (15.04%)  2/8 (25.00%)  3/6 (50.00%)  2/123 (1.63%) 
Metastases to central nervous system  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Metastasis  1  2/113 (1.77%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Neuroendocrine carcinoma of the skin  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Prostate cancer  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Squamous cell carcinoma of skin  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Transitional cell carcinoma  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Tumour haemorrhage  1  0/113 (0.00%)  1/195 (0.51%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Tumour obstruction  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  1/6 (16.67%)  0/123 (0.00%) 
Tumour pain  1  1/113 (0.88%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Nervous system disorders             
Basal ganglia infarction  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Bell's palsy  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Carotid artery aneurysm  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Cerebral haemorrhage  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Cerebral infarction  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Cerebral ischaemia  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Cerebrovascular accident  1  1/113 (0.88%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Depressed level of consciousness  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Dizziness  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Embolic stroke  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Encephalopathy  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Guillain-Barre syndrome  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Haemorrhage intracranial  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Headache  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Intraventricular haemorrhage  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Monoparesis  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Myasthenia gravis  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Peripheral motor neuropathy  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Peripheral sensory neuropathy  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Seizure  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Spinal cord compression  1  0/113 (0.00%)  3/195 (1.54%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Syncope  1  1/113 (0.88%)  3/195 (1.54%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Product Issues             
Device occlusion  1  1/113 (0.88%)  2/195 (1.03%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Psychiatric disorders             
Confusional state  1  0/113 (0.00%)  3/195 (1.54%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Mental status changes  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Renal and urinary disorders             
Acute kidney injury  1  2/113 (1.77%)  5/195 (2.56%)  8/133 (6.02%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Autoimmune nephritis  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Haematuria  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Hydronephrosis  1  0/113 (0.00%)  2/195 (1.03%)  2/133 (1.50%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Oliguria  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Renal colic  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Renal failure  1  0/113 (0.00%)  3/195 (1.54%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Renal haematoma  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Ureteric stenosis  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Urinary incontinence  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Urinary retention  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Urinary tract obstruction  1  0/113 (0.00%)  2/195 (1.03%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Urogenital fistula  1  1/113 (0.88%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Reproductive system and breast disorders             
Female genital tract fistula  1  0/113 (0.00%)  1/195 (0.51%)  2/133 (1.50%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Pelvic pain  1  0/113 (0.00%)  1/195 (0.51%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Prostatic obstruction  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Vaginal haemorrhage  1  0/113 (0.00%)  0/195 (0.00%)  2/133 (1.50%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Vulval disorder  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Acute respiratory distress syndrome  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Aspiration  1  0/113 (0.00%)  3/195 (1.54%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  2/123 (1.63%) 
Dyspnoea  1  4/113 (3.54%)  2/195 (1.03%)  1/133 (0.75%)  3/8 (37.50%)  0/6 (0.00%)  0/123 (0.00%) 
Haemoptysis  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Hypoxia  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Immune-mediated lung disease  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Laryngeal oedema  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Lung disorder  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Pleural effusion  1  1/113 (0.88%)  3/195 (1.54%)  1/133 (0.75%)  1/8 (12.50%)  0/6 (0.00%)  0/123 (0.00%) 
Pneumonitis  1  4/113 (3.54%)  7/195 (3.59%)  10/133 (7.52%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Pneumothorax  1  1/113 (0.88%)  2/195 (1.03%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Productive cough  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Pulmonary embolism  1  1/113 (0.88%)  2/195 (1.03%)  2/133 (1.50%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Pulmonary haemorrhage  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  1/8 (12.50%)  0/6 (0.00%)  0/123 (0.00%) 
Stridor  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  1/8 (12.50%)  0/6 (0.00%)  0/123 (0.00%) 
Skin and subcutaneous tissue disorders             
Hyperhidrosis  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Rash  1  0/113 (0.00%)  2/195 (1.03%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Rash maculo-papular  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Rash pruritic  1  0/113 (0.00%)  0/195 (0.00%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Surgical and medical procedures             
Debridement  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Vascular disorders             
Arterial haemorrhage  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Deep vein thrombosis  1  0/113 (0.00%)  2/195 (1.03%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Embolism  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Haematoma  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Hypotension  1  2/113 (1.77%)  1/195 (0.51%)  1/133 (0.75%)  0/8 (0.00%)  1/6 (16.67%)  0/123 (0.00%) 
Iliac vein stenosis  1  0/113 (0.00%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Lymphoedema  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Orthostatic hypotension  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
1
Term from vocabulary, 24.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Metastatic Monotherapy Metastatic Combo A Metastatic Combo B Metastatic Combo C Metastatic Combo D Neoadjuvant
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   110/113 (97.35%)   189/195 (96.92%)   129/133 (96.99%)   7/8 (87.50%)   5/6 (83.33%)   108/123 (87.80%) 
Blood and lymphatic system disorders             
Anaemia  1  28/113 (24.78%)  53/195 (27.18%)  42/133 (31.58%)  2/8 (25.00%)  2/6 (33.33%)  11/123 (8.94%) 
Ear and labyrinth disorders             
Ear pain  1  3/113 (2.65%)  4/195 (2.05%)  1/133 (0.75%)  0/8 (0.00%)  1/6 (16.67%)  2/123 (1.63%) 
Vertigo  1  6/113 (5.31%)  1/195 (0.51%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Endocrine disorders             
Hyperthyroidism  1  2/113 (1.77%)  9/195 (4.62%)  21/133 (15.79%)  0/8 (0.00%)  0/6 (0.00%)  4/123 (3.25%) 
Hypothyroidism  1  17/113 (15.04%)  39/195 (20.00%)  31/133 (23.31%)  2/8 (25.00%)  1/6 (16.67%)  3/123 (2.44%) 
Gastrointestinal disorders             
Abdominal pain  1  18/113 (15.93%)  29/195 (14.87%)  30/133 (22.56%)  1/8 (12.50%)  0/6 (0.00%)  8/123 (6.50%) 
Abdominal pain upper  1  12/113 (10.62%)  8/195 (4.10%)  4/133 (3.01%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Colitis  1  2/113 (1.77%)  6/195 (3.08%)  7/133 (5.26%)  0/8 (0.00%)  0/6 (0.00%)  4/123 (3.25%) 
Constipation  1  27/113 (23.89%)  51/195 (26.15%)  37/133 (27.82%)  1/8 (12.50%)  0/6 (0.00%)  21/123 (17.07%) 
Diarrhoea  1  31/113 (27.43%)  61/195 (31.28%)  54/133 (40.60%)  1/8 (12.50%)  2/6 (33.33%)  22/123 (17.89%) 
Dry mouth  1  8/113 (7.08%)  12/195 (6.15%)  6/133 (4.51%)  1/8 (12.50%)  0/6 (0.00%)  6/123 (4.88%) 
Dyspepsia  1  4/113 (3.54%)  11/195 (5.64%)  7/133 (5.26%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Dysphagia  1  10/113 (8.85%)  12/195 (6.15%)  2/133 (1.50%)  4/8 (50.00%)  0/6 (0.00%)  21/123 (17.07%) 
Nausea  1  25/113 (22.12%)  45/195 (23.08%)  48/133 (36.09%)  2/8 (25.00%)  3/6 (50.00%)  42/123 (34.15%) 
Stomatitis  1  7/113 (6.19%)  5/195 (2.56%)  4/133 (3.01%)  0/8 (0.00%)  0/6 (0.00%)  5/123 (4.07%) 
Tongue ulceration  1  0/113 (0.00%)  1/195 (0.51%)  1/133 (0.75%)  1/8 (12.50%)  0/6 (0.00%)  0/123 (0.00%) 
Vomiting  1  21/113 (18.58%)  31/195 (15.90%)  33/133 (24.81%)  1/8 (12.50%)  0/6 (0.00%)  14/123 (11.38%) 
General disorders             
Asthenia  1  18/113 (15.93%)  26/195 (13.33%)  23/133 (17.29%)  0/8 (0.00%)  0/6 (0.00%)  11/123 (8.94%) 
Chest pain  1  6/113 (5.31%)  2/195 (1.03%)  1/133 (0.75%)  1/8 (12.50%)  0/6 (0.00%)  0/123 (0.00%) 
Chills  1  6/113 (5.31%)  10/195 (5.13%)  9/133 (6.77%)  0/8 (0.00%)  0/6 (0.00%)  3/123 (2.44%) 
Face oedema  1  2/113 (1.77%)  6/195 (3.08%)  1/133 (0.75%)  0/8 (0.00%)  1/6 (16.67%)  3/123 (2.44%) 
Facial pain  1  3/113 (2.65%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  1/6 (16.67%)  3/123 (2.44%) 
Fatigue  1  47/113 (41.59%)  81/195 (41.54%)  46/133 (34.59%)  6/8 (75.00%)  1/6 (16.67%)  40/123 (32.52%) 
Gait disturbance  1  0/113 (0.00%)  2/195 (1.03%)  1/133 (0.75%)  0/8 (0.00%)  1/6 (16.67%)  0/123 (0.00%) 
Inflammation  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  1/6 (16.67%)  0/123 (0.00%) 
Influenza like illness  1  4/113 (3.54%)  12/195 (6.15%)  2/133 (1.50%)  0/8 (0.00%)  0/6 (0.00%)  3/123 (2.44%) 
Localised oedema  1  0/113 (0.00%)  2/195 (1.03%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  8/123 (6.50%) 
Malaise  1  4/113 (3.54%)  3/195 (1.54%)  0/133 (0.00%)  1/8 (12.50%)  0/6 (0.00%)  0/123 (0.00%) 
Mucosal inflammation  1  4/113 (3.54%)  6/195 (3.08%)  5/133 (3.76%)  0/8 (0.00%)  0/6 (0.00%)  15/123 (12.20%) 
Non-cardiac chest pain  1  5/113 (4.42%)  3/195 (1.54%)  3/133 (2.26%)  1/8 (12.50%)  0/6 (0.00%)  2/123 (1.63%) 
Oedema peripheral  1  16/113 (14.16%)  21/195 (10.77%)  20/133 (15.04%)  1/8 (12.50%)  2/6 (33.33%)  6/123 (4.88%) 
Pain  1  3/113 (2.65%)  9/195 (4.62%)  4/133 (3.01%)  1/8 (12.50%)  1/6 (16.67%)  2/123 (1.63%) 
Pyrexia  1  14/113 (12.39%)  34/195 (17.44%)  33/133 (24.81%)  0/8 (0.00%)  2/6 (33.33%)  13/123 (10.57%) 
Infections and infestations             
Bronchitis  1  8/113 (7.08%)  3/195 (1.54%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Candida infection  1  3/113 (2.65%)  5/195 (2.56%)  0/133 (0.00%)  1/8 (12.50%)  0/6 (0.00%)  3/123 (2.44%) 
Conjunctivitis  1  6/113 (5.31%)  4/195 (2.05%)  3/133 (2.26%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Eye infection  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  1/6 (16.67%)  0/123 (0.00%) 
Mucosal infection  1  2/113 (1.77%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  1/6 (16.67%)  1/123 (0.81%) 
Nasopharyngitis  1  10/113 (8.85%)  14/195 (7.18%)  3/133 (2.26%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Oral bacterial infection  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  1/8 (12.50%)  0/6 (0.00%)  0/123 (0.00%) 
Otitis externa  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  1/8 (12.50%)  0/6 (0.00%)  0/123 (0.00%) 
Respiratory tract infection  1  3/113 (2.65%)  7/195 (3.59%)  2/133 (1.50%)  0/8 (0.00%)  1/6 (16.67%)  0/123 (0.00%) 
Rhinitis  1  6/113 (5.31%)  4/195 (2.05%)  3/133 (2.26%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Tracheitis  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  1/6 (16.67%)  0/123 (0.00%) 
Upper respiratory tract infection  1  7/113 (6.19%)  27/195 (13.85%)  8/133 (6.02%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Urinary tract infection  1  9/113 (7.96%)  21/195 (10.77%)  31/133 (23.31%)  0/8 (0.00%)  0/6 (0.00%)  9/123 (7.32%) 
Injury, poisoning and procedural complications             
Fall  1  0/113 (0.00%)  1/195 (0.51%)  2/133 (1.50%)  1/8 (12.50%)  0/6 (0.00%)  0/123 (0.00%) 
Fracture  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  1/8 (12.50%)  0/6 (0.00%)  0/123 (0.00%) 
Infusion related reaction  1  5/113 (4.42%)  11/195 (5.64%)  4/133 (3.01%)  0/8 (0.00%)  0/6 (0.00%)  4/123 (3.25%) 
Jaw fracture  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  1/8 (12.50%)  0/6 (0.00%)  0/123 (0.00%) 
Procedural pain  1  3/113 (2.65%)  3/195 (1.54%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  9/123 (7.32%) 
Radiation skin injury  1  1/113 (0.88%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  15/123 (12.20%) 
Investigations             
Alanine aminotransferase increased  1  8/113 (7.08%)  26/195 (13.33%)  22/133 (16.54%)  0/8 (0.00%)  0/6 (0.00%)  4/123 (3.25%) 
Amylase increased  1  6/113 (5.31%)  20/195 (10.26%)  12/133 (9.02%)  1/8 (12.50%)  0/6 (0.00%)  7/123 (5.69%) 
Aspartate aminotransferase increased  1  10/113 (8.85%)  25/195 (12.82%)  20/133 (15.04%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Blood alkaline phosphatase increased  1  5/113 (4.42%)  9/195 (4.62%)  7/133 (5.26%)  0/8 (0.00%)  0/6 (0.00%)  3/123 (2.44%) 
Blood creatinine increased  1  11/113 (9.73%)  19/195 (9.74%)  13/133 (9.77%)  0/8 (0.00%)  0/6 (0.00%)  4/123 (3.25%) 
Breath sounds abnormal  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  1/8 (12.50%)  0/6 (0.00%)  1/123 (0.81%) 
Lipase increased  1  17/113 (15.04%)  27/195 (13.85%)  17/133 (12.78%)  2/8 (25.00%)  0/6 (0.00%)  7/123 (5.69%) 
Lymphocyte count decreased  1  1/113 (0.88%)  16/195 (8.21%)  3/133 (2.26%)  0/8 (0.00%)  0/6 (0.00%)  2/123 (1.63%) 
Platelet count decreased  1  0/113 (0.00%)  11/195 (5.64%)  0/133 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Troponin increased  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  1/8 (12.50%)  0/6 (0.00%)  0/123 (0.00%) 
Weight decreased  1  10/113 (8.85%)  24/195 (12.31%)  8/133 (6.02%)  2/8 (25.00%)  0/6 (0.00%)  15/123 (12.20%) 
White blood cell count decreased  1  2/113 (1.77%)  10/195 (5.13%)  4/133 (3.01%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Metabolism and nutrition disorders             
Decreased appetite  1  24/113 (21.24%)  48/195 (24.62%)  32/133 (24.06%)  2/8 (25.00%)  1/6 (16.67%)  15/123 (12.20%) 
Dehydration  1  1/113 (0.88%)  9/195 (4.62%)  3/133 (2.26%)  0/8 (0.00%)  0/6 (0.00%)  8/123 (6.50%) 
Hypercalcaemia  1  3/113 (2.65%)  9/195 (4.62%)  4/133 (3.01%)  0/8 (0.00%)  1/6 (16.67%)  2/123 (1.63%) 
Hyperglycaemia  1  3/113 (2.65%)  16/195 (8.21%)  9/133 (6.77%)  0/8 (0.00%)  0/6 (0.00%)  3/123 (2.44%) 
Hypoalbuminaemia  1  2/113 (1.77%)  14/195 (7.18%)  16/133 (12.03%)  0/8 (0.00%)  0/6 (0.00%)  2/123 (1.63%) 
Hypokalaemia  1  6/113 (5.31%)  20/195 (10.26%)  15/133 (11.28%)  1/8 (12.50%)  0/6 (0.00%)  11/123 (8.94%) 
Hypomagnesaemia  1  10/113 (8.85%)  14/195 (7.18%)  17/133 (12.78%)  1/8 (12.50%)  0/6 (0.00%)  10/123 (8.13%) 
Hyponatraemia  1  4/113 (3.54%)  24/195 (12.31%)  14/133 (10.53%)  1/8 (12.50%)  1/6 (16.67%)  9/123 (7.32%) 
Hypophosphataemia  1  5/113 (4.42%)  20/195 (10.26%)  3/133 (2.26%)  1/8 (12.50%)  0/6 (0.00%)  4/123 (3.25%) 
Musculoskeletal and connective tissue disorders             
Arthralgia  1  24/113 (21.24%)  35/195 (17.95%)  26/133 (19.55%)  2/8 (25.00%)  1/6 (16.67%)  10/123 (8.13%) 
Back pain  1  17/113 (15.04%)  28/195 (14.36%)  19/133 (14.29%)  1/8 (12.50%)  1/6 (16.67%)  4/123 (3.25%) 
Flank pain  1  6/113 (5.31%)  7/195 (3.59%)  7/133 (5.26%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Groin pain  1  2/113 (1.77%)  3/195 (1.54%)  2/133 (1.50%)  1/8 (12.50%)  0/6 (0.00%)  0/123 (0.00%) 
Muscular weakness  1  2/113 (1.77%)  10/195 (5.13%)  4/133 (3.01%)  1/8 (12.50%)  0/6 (0.00%)  4/123 (3.25%) 
Musculoskeletal chest pain  1  8/113 (7.08%)  11/195 (5.64%)  2/133 (1.50%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Musculoskeletal pain  1  4/113 (3.54%)  5/195 (2.56%)  2/133 (1.50%)  1/8 (12.50%)  0/6 (0.00%)  0/123 (0.00%) 
Myalgia  1  10/113 (8.85%)  19/195 (9.74%)  10/133 (7.52%)  0/8 (0.00%)  0/6 (0.00%)  6/123 (4.88%) 
Neck pain  1  3/113 (2.65%)  7/195 (3.59%)  1/133 (0.75%)  1/8 (12.50%)  0/6 (0.00%)  6/123 (4.88%) 
Pain in extremity  1  12/113 (10.62%)  13/195 (6.67%)  9/133 (6.77%)  0/8 (0.00%)  0/6 (0.00%)  4/123 (3.25%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Squamous cell carcinoma of skin  1  3/113 (2.65%)  1/195 (0.51%)  0/133 (0.00%)  0/8 (0.00%)  1/6 (16.67%)  0/123 (0.00%) 
Tumour pain  1  7/113 (6.19%)  5/195 (2.56%)  3/133 (2.26%)  1/8 (12.50%)  0/6 (0.00%)  1/123 (0.81%) 
Nervous system disorders             
Dizziness  1  12/113 (10.62%)  19/195 (9.74%)  15/133 (11.28%)  0/8 (0.00%)  0/6 (0.00%)  6/123 (4.88%) 
Dysgeusia  1  7/113 (6.19%)  3/195 (1.54%)  3/133 (2.26%)  0/8 (0.00%)  0/6 (0.00%)  10/123 (8.13%) 
Headache  1  13/113 (11.50%)  31/195 (15.90%)  22/133 (16.54%)  0/8 (0.00%)  2/6 (33.33%)  6/123 (4.88%) 
Paraesthesia  1  2/113 (1.77%)  3/195 (1.54%)  2/133 (1.50%)  2/8 (25.00%)  0/6 (0.00%)  3/123 (2.44%) 
Peripheral sensory neuropathy  1  2/113 (1.77%)  4/195 (2.05%)  4/133 (3.01%)  0/8 (0.00%)  1/6 (16.67%)  8/123 (6.50%) 
Psychiatric disorders             
Anxiety  1  10/113 (8.85%)  8/195 (4.10%)  4/133 (3.01%)  1/8 (12.50%)  0/6 (0.00%)  9/123 (7.32%) 
Confusional state  1  1/113 (0.88%)  5/195 (2.56%)  2/133 (1.50%)  0/8 (0.00%)  1/6 (16.67%)  0/123 (0.00%) 
Insomnia  1  10/113 (8.85%)  23/195 (11.79%)  8/133 (6.02%)  1/8 (12.50%)  1/6 (16.67%)  2/123 (1.63%) 
Reproductive system and breast disorders             
Pelvic pain  1  2/113 (1.77%)  6/195 (3.08%)  7/133 (5.26%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Vaginal haemorrhage  1  1/113 (0.88%)  6/195 (3.08%)  7/133 (5.26%)  0/8 (0.00%)  0/6 (0.00%)  4/123 (3.25%) 
Respiratory, thoracic and mediastinal disorders             
Aspiration  1  0/113 (0.00%)  4/195 (2.05%)  0/133 (0.00%)  0/8 (0.00%)  1/6 (16.67%)  3/123 (2.44%) 
Cough  1  26/113 (23.01%)  49/195 (25.13%)  17/133 (12.78%)  2/8 (25.00%)  1/6 (16.67%)  7/123 (5.69%) 
Dyspnoea  1  21/113 (18.58%)  30/195 (15.38%)  13/133 (9.77%)  2/8 (25.00%)  1/6 (16.67%)  3/123 (2.44%) 
Dyspnoea exertional  1  7/113 (6.19%)  4/195 (2.05%)  1/133 (0.75%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Laryngeal inflammation  1  0/113 (0.00%)  0/195 (0.00%)  0/133 (0.00%)  1/8 (12.50%)  0/6 (0.00%)  1/123 (0.81%) 
Nasal congestion  1  5/113 (4.42%)  11/195 (5.64%)  4/133 (3.01%)  0/8 (0.00%)  0/6 (0.00%)  1/123 (0.81%) 
Oropharyngeal pain  1  6/113 (5.31%)  10/195 (5.13%)  3/133 (2.26%)  0/8 (0.00%)  1/6 (16.67%)  6/123 (4.88%) 
Pleural effusion  1  4/113 (3.54%)  4/195 (2.05%)  1/133 (0.75%)  1/8 (12.50%)  0/6 (0.00%)  0/123 (0.00%) 
Pneumonitis  1  8/113 (7.08%)  9/195 (4.62%)  9/133 (6.77%)  0/8 (0.00%)  0/6 (0.00%)  0/123 (0.00%) 
Productive cough  1  3/113 (2.65%)  7/195 (3.59%)  7/133 (5.26%)  0/8 (0.00%)  0/6 (0.00%)  3/123 (2.44%) 
Upper-airway cough syndrome  1  0/113 (0.00%)  6/195 (3.08%)  1/133 (0.75%)  1/8 (12.50%)  0/6 (0.00%)  1/123 (0.81%) 
Skin and subcutaneous tissue disorders             
Dry skin  1  10/113 (8.85%)  14/195 (7.18%)  12/133 (9.02%)  0/8 (0.00%)  1/6 (16.67%)  3/123 (2.44%) 
Night sweats  1  1/113 (0.88%)  3/195 (1.54%)  1/133 (0.75%)  1/8 (12.50%)  0/6 (0.00%)  1/123 (0.81%) 
Pruritus  1  23/113 (20.35%)  60/195 (30.77%)  34/133 (25.56%)  0/8 (0.00%)  1/6 (16.67%)  11/123 (8.94%) 
Rash  1  17/113 (15.04%)  49/195 (25.13%)  16/133 (12.03%)  1/8 (12.50%)  0/6 (0.00%)  7/123 (5.69%) 
Rash maculo-papular  1  8/113 (7.08%)  20/195 (10.26%)  25/133 (18.80%)  0/8 (0.00%)  0/6 (0.00%)  6/123 (4.88%) 
Skin ulcer  1  0/113 (0.00%)  2/195 (1.03%)  1/133 (0.75%)  0/8 (0.00%)  2/6 (33.33%)  0/123 (0.00%) 
Vascular disorders             
Haematoma  1  2/113 (1.77%)  2/195 (1.03%)  0/133 (0.00%)  1/8 (12.50%)  0/6 (0.00%)  2/123 (1.63%) 
Hypertension  1  10/113 (8.85%)  7/195 (3.59%)  5/133 (3.76%)  1/8 (12.50%)  0/6 (0.00%)  12/123 (9.76%) 
Hypotension  1  5/113 (4.42%)  10/195 (5.13%)  4/133 (3.01%)  0/8 (0.00%)  1/6 (16.67%)  4/123 (3.25%) 
Lymphoedema  1  4/113 (3.54%)  4/195 (2.05%)  5/133 (3.76%)  1/8 (12.50%)  1/6 (16.67%)  2/123 (1.63%) 
Venous thrombosis  1  1/113 (0.88%)  0/195 (0.00%)  0/133 (0.00%)  0/8 (0.00%)  1/6 (16.67%)  0/123 (0.00%) 
1
Term from vocabulary, 24.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Phone: Please Email
EMail: Clinical.Trials@bms.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02488759    
Other Study ID Numbers: CA209-358
2015-000230-29 ( EudraCT Number )
First Submitted: June 30, 2015
First Posted: July 2, 2015
Results First Submitted: March 17, 2022
Results First Posted: April 12, 2022
Last Update Posted: July 7, 2022