Trial Outcomes & Findings for Study of Tremelimumab in Patients With Advanced Solid Tumors (NCT NCT02527434)

NCT ID: NCT02527434

Last Updated: 2023-11-15

Results Overview

Objective response rate (ORR) during the initial tremelimumab monotherapy phase was assessed by the site Investigator using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) and was defined as the percentage of patients with a confirmed overall response of complete response (CR) or partial response (PR) and was based on all treated patients who had measurable disease at baseline (Day 1). 95% confidence intervals (CIs) were calculated using the Clopper Pearson method.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 64 participants
• Primary outcome timeframe: From baseline to 12 months in the tremelimumab monotherapy phase
• Results posted on: 2023-11-15

Participant Flow

A total of 64 patients with select advanced solid tumors were treated in this phase II, open-label, multi-center study from November 2015. Primary data cut off date: 17 February 2018. Final data cut off date: 31 December 2018.

The patients were split into 3 different analysis cohorts based on their tumor types: urothelial bladder cancer (UBC), triple-negative breast cancer (TNBC) and pancreatic ductal adenocarcinoma (PDAC).

Participant milestones

Measure	UBC Cohort Patients with UBC entered the initial tremelimumab monotherapy phase and were administered tremelimumab via intravenous (IV) infusion at a dose of 750 milligrams (mg) once every 4 weeks (q4w) for 7 doses (cycles), then every 12 weeks (q12w) for 2 additional cycles, for up to a total of 12 months or until confirmed progressive disease (PD). Eligible patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were given the option for retreatment with tremelimumab monotherapy or to be sequenced to receive MEDI4736 (durvalumab) + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months or to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.	TNBC Cohort Patients with TNBC entered the initial tremelimumab monotherapy phase and were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD. Eligible patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were given the option for retreatment with tremelimumab monotherapy or to be sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months or to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.	PDAC Cohort Patients with PDAC entered the initial tremelimumab monotherapy phase and were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD. Eligible patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were given the option for retreatment with tremelimumab monotherapy or to be sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months or to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
Overall Study STARTED	32	12	20
Overall Study Started Retreatment Phase (COMBO)	7	5	4
Overall Study Started Retreatment Phase (MEDI)	4	0	1
Overall Study COMPLETED	4	1	0
Overall Study NOT COMPLETED	28	11	20

Reasons for withdrawal

Measure	UBC Cohort Patients with UBC entered the initial tremelimumab monotherapy phase and were administered tremelimumab via intravenous (IV) infusion at a dose of 750 milligrams (mg) once every 4 weeks (q4w) for 7 doses (cycles), then every 12 weeks (q12w) for 2 additional cycles, for up to a total of 12 months or until confirmed progressive disease (PD). Eligible patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were given the option for retreatment with tremelimumab monotherapy or to be sequenced to receive MEDI4736 (durvalumab) + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months or to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.	TNBC Cohort Patients with TNBC entered the initial tremelimumab monotherapy phase and were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD. Eligible patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were given the option for retreatment with tremelimumab monotherapy or to be sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months or to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.	PDAC Cohort Patients with PDAC entered the initial tremelimumab monotherapy phase and were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD. Eligible patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were given the option for retreatment with tremelimumab monotherapy or to be sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months or to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
Overall Study Lost to Follow-up	2	2	0
Overall Study Death	19	6	17
Overall Study Withdrawal by Subject	5	3	3
Overall Study Reason Not Specified	1	0	0
Overall Study Site closure	1	0	0

Baseline Characteristics

Study of Tremelimumab in Patients With Advanced Solid Tumors

Baseline characteristics by cohort

Measure	UBC Cohort n=32 Participants Patients with UBC entered the initial tremelimumab monotherapy phase and were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD. Eligible patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were given the option for retreatment with tremelimumab monotherapy or to be sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months or to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.	TNBC Cohort n=12 Participants Patients with TNBC entered the initial tremelimumab monotherapy phase and were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD. Eligible patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were given the option for retreatment with tremelimumab monotherapy or to be sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months or to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.	PDAC Cohort n=20 Participants Patients with PDAC entered the initial tremelimumab monotherapy phase and were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD. Eligible patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were given the option for retreatment with tremelimumab monotherapy or to be sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months or to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.	Total n=64 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants	35 Participants n=4 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	29 Participants n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	12 Participants n=7 Participants	9 Participants n=5 Participants	27 Participants n=4 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	0 Participants n=7 Participants	11 Participants n=5 Participants	37 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants	63 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants	32 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants	30 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: From baseline to 12 months in the tremelimumab monotherapy phase

Population: Analysis was performed on the FAS (all treated patients who received at least 1 dose of tremelimumab monotherapy).

Objective response rate (ORR) during the initial tremelimumab monotherapy phase was assessed by the site Investigator using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) and was defined as the percentage of patients with a confirmed overall response of complete response (CR) or partial response (PR) and was based on all treated patients who had measurable disease at baseline (Day 1). 95% confidence intervals (CIs) were calculated using the Clopper Pearson method.

Outcome measures

Measure	UBC - Tremelimumab Monotherapy n=32 Participants Patients with UBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	TNBC - Tremelimumab Monotherapy n=12 Participants Patients with TNBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	PDAC - Tremelimumab Monotherapy n=20 Participants Patients with PDAC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	UBC- MEDI Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.	PDAC - MEDI Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
Percentage of Patients With Confirmed Overall Response During Tremelimumab Monotherapy Phase	18.8 Percentage of Patients Interval 7.2 to 36.4	8.3 Percentage of Patients Interval 0.2 to 38.5	0.0 Percentage of Patients Interval 0.0 to 16.8	—	—

SECONDARY outcome

Timeframe: From baseline to 12 months in the tremelimumab monotherapy phase

Population: Analysis was performed on the FAS (all treated patients who received at least 1 dose of tremelimumab monotherapy).

DoR during the initial tremelimumab monotherapy phase was assessed by the site Investigator using RECIST 1.1 and was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression. The time of the initial response was defined as the latest of the dates contributing toward the first visit response of CR or PR. If a patient did not progress following a response, then their DoR was censored at the progression-free survival (PFS) censoring time. DoR was not defined for those patients who did not have documented response. Median DoR was calculated using the Kaplan-Meier technique.

Outcome measures

Measure	UBC - Tremelimumab Monotherapy n=32 Participants Patients with UBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	TNBC - Tremelimumab Monotherapy n=12 Participants Patients with TNBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	PDAC - Tremelimumab Monotherapy n=20 Participants Patients with PDAC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	UBC- MEDI Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.	PDAC - MEDI Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
Median Duration of Response (DoR) During Tremelimumab Monotherapy Phase	NA Months DoR was not estimable in this cohort	12.9 Months Interval 12.9 to 12.9	NA Months DoR was not estimable in this cohort	—	—

SECONDARY outcome

Timeframe: From baseline to 12 months in the tremelimumab monotherapy phase

Population: Analysis was performed on the FAS (all treated patients who received at least 1 dose of tremelimumab monotherapy).

DCR during the initial tremelimumab monotherapy phase was defined as the percentage of patients who had a best objective response (BoR) of CR or PR in the first 3 months (PDAC patients) or 4 months (UBC and TNBC patients) and 12 months (all patients), or who had demonstrated stable disease (SD) for a minimum interval of 3, 4 or 12 months following the start of study treatment. DCR was determined programmatically based on RECIST 1.1 using site Investigator data and all data up until the first progression event. 95% CIs were calculated using the Clopper Pearson method.

Outcome measures

Measure	UBC - Tremelimumab Monotherapy n=32 Participants Patients with UBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	TNBC - Tremelimumab Monotherapy n=12 Participants Patients with TNBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	PDAC - Tremelimumab Monotherapy n=20 Participants Patients with PDAC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	UBC- MEDI Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.	PDAC - MEDI Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
Disease Control Rate (DCR) During Tremelimumab Monotherapy Phase DCR at 3 or 4 months	25.0 Percentage of patients Interval 11.46 to 43.4	8.3 Percentage of patients Interval 0.21 to 38.48	0.0 Percentage of patients Interval 0.0 to 16.84	—	—
Disease Control Rate (DCR) During Tremelimumab Monotherapy Phase DCR at 12 months	21.9 Percentage of patients Interval 9.28 to 39.97	8.3 Percentage of patients Interval 0.21 to 38.48	0.0 Percentage of patients Interval 0.0 to 16.84	—	—

SECONDARY outcome

Timeframe: From baseline to 12 months in the tremelimumab monotherapy phase

Population: Analysis was performed on the FAS (all treated patients who received at least 1 dose of tremelimumab monotherapy).

PFS during the initial tremelimumab monotherapy phase was assessed by the site Investigator using RECIST 1.1 and was defined as the time from the date of enrollment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from therapy or received another anticancer therapy prior to progression. Progression events that did not occur within 3 months (PDAC patients) or 4 months (UBC/TNBC patients) of the last evaluable assessment (or first dose) were censored. Median PFS was calculated using the Kaplan-Meier technique.

Outcome measures

Measure	UBC - Tremelimumab Monotherapy n=32 Participants Patients with UBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	TNBC - Tremelimumab Monotherapy n=12 Participants Patients with TNBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	PDAC - Tremelimumab Monotherapy n=20 Participants Patients with PDAC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	UBC- MEDI Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.	PDAC - MEDI Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
Median PFS During Tremelimumab Monotherapy Phase	2.63 Months Interval 1.77 to The upper limit was not estimable in this cohort.	3.58 Months Interval 1.4 to 4.04	1.77 Months Interval 1.38 to 2.92	—	—

SECONDARY outcome

Timeframe: From baseline to 12 months in the tremelimumab monotherapy phase

Population: Analysis was performed on the FAS (all treated patients who received at least 1 dose of tremelimumab monotherapy).

BoR during the initial tremelimumab monotherapy phase was calculated based on the overall visit responses from each RECIST 1.1 assessment and was defined as the best response a patient had during their time in the study (from CR, PR, SD, PD or not evaluable [NE]) obtained among all tumor assessment visits from baseline until end of treatment or determination of PD. The BoR was summarized by percentage of patients for each category (CR, PR, SD, PD, and NE).

Outcome measures

Measure	UBC - Tremelimumab Monotherapy n=32 Participants Patients with UBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	TNBC - Tremelimumab Monotherapy n=12 Participants Patients with TNBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	PDAC - Tremelimumab Monotherapy n=20 Participants Patients with PDAC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	UBC- MEDI Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.	PDAC - MEDI Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
Best Objective Response (BoR) During Tremelimumab Monotherapy Phase CR	6.3 Percentage of Patients	0.0 Percentage of Patients	0.0 Percentage of Patients	—	—
Best Objective Response (BoR) During Tremelimumab Monotherapy Phase PR	12.5 Percentage of Patients	8.3 Percentage of Patients	0.0 Percentage of Patients	—	—
Best Objective Response (BoR) During Tremelimumab Monotherapy Phase SD	9.4 Percentage of Patients	0.0 Percentage of Patients	0.0 Percentage of Patients	—	—
Best Objective Response (BoR) During Tremelimumab Monotherapy Phase PD	68.8 Percentage of Patients	91.7 Percentage of Patients	90.0 Percentage of Patients	—	—
Best Objective Response (BoR) During Tremelimumab Monotherapy Phase NE	3.1 Percentage of Patients	0.0 Percentage of Patients	10.0 Percentage of Patients	—	—

SECONDARY outcome

Timeframe: From baseline to final data cut-off date

Population: Analysis was performed on the FAS (all treated patients who received at least 1 dose of tremelimumab monotherapy).

OS was defined as the time from the date of first dose until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. OS is presented from start of tremelimumab monotherapy phase and includes the retreatment phase if the patient entered the corresponding treatment phase.

Median OS was calculated using the Kaplan-Meier technique.

Outcome measures

Measure	UBC - Tremelimumab Monotherapy n=32 Participants Patients with UBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	TNBC - Tremelimumab Monotherapy n=12 Participants Patients with TNBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	PDAC - Tremelimumab Monotherapy n=20 Participants Patients with PDAC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	UBC- MEDI Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.	PDAC - MEDI Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
Median Overall Survival (OS) During Tremelimumab Monotherapy Phase	10.32 Months Interval 5.91 to 24.61	12.88 Months Interval 2.53 to Upper limit was not estimable in this cohort.	3.98 Months Interval 2.83 to 5.13	—	—

SECONDARY outcome

Timeframe: From baseline to 12 months in retreatment phase

Population: Analysis was performed on the MEDI and COMBO analysis sets (all patients who were treated with tremelimumab, received at least 1 dose of durvalumab monotherapy or durvalumab + tremelimumab combination therapy as applicable, and who had a baseline tumor assessment prior to dosing).

ORR was assessed by the site Investigator using RECIST 1.1 and was defined as the percentage of patients with a confirmed overall response of CR or PR and was based on all treated patients who had measurable disease at baseline (Day 1) and who sequenced to durvalumab monotherapy (MEDI treatment phase) or durvalumab + tremelimumab combination therapy (COMBO treatment phase). 95% CIs were calculated using the Clopper Pearson method.

Outcome measures

Measure	UBC - Tremelimumab Monotherapy n=7 Participants Patients with UBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	TNBC - Tremelimumab Monotherapy n=5 Participants Patients with TNBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	PDAC - Tremelimumab Monotherapy n=4 Participants Patients with PDAC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	UBC- MEDI n=4 Participants Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.	PDAC - MEDI n=1 Participants Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
Percentage of Patients With Confirmed Overall Response During Retreatment Phase	0.0 Percentage of Patients Interval 0.0 to 41.0	0.0 Percentage of Patients Interval 0.0 to 52.2	0.0 Percentage of Patients Interval 0.0 to 60.2	25.0 Percentage of Patients Interval 0.6 to 80.6	0.0 Percentage of Patients Interval 0.0 to 97.5

SECONDARY outcome

Timeframe: From baseline to 12 months in retreatment phase

Population: Analysis was performed on the MEDI and COMBO analysis sets (all patients who were treated with tremelimumab, received at least 1 dose of durvalumab monotherapy or durvalumab + tremelimumab combination therapy as applicable, and who had a baseline tumor assessment prior to dosing).

DoR during the retreatment phase was assessed by the site Investigator using RECIST 1.1 and was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression. The time of the initial response was defined as the latest of the dates contributing toward the first visit response of CR or PR. If a patient did not progress following a response, then their DoR was censored at the PFS censoring time. DoR was not defined for those patients who did not have documented response. Median DoR was calculated using the Kaplan-Meier technique.

Outcome measures

Measure	UBC - Tremelimumab Monotherapy n=7 Participants Patients with UBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	TNBC - Tremelimumab Monotherapy n=5 Participants Patients with TNBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	PDAC - Tremelimumab Monotherapy n=4 Participants Patients with PDAC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	UBC- MEDI n=4 Participants Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.	PDAC - MEDI n=1 Participants Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
Median DoR During Retreatment Phase	NA Months No DoR data were available for this cohort.	NA Months No DoR data were available for this cohort.	NA Months No DoR data were available for this cohort.	7.3 Months Interval 7.3 to 7.3	NA Months DoR was not estimable in this cohort

SECONDARY outcome

Timeframe: From baseline to 4 months in retreatment phase

Population: Analysis was performed on the MEDI and COMBO analysis sets (all patients who were treated with tremelimumab, received at least 1 dose of durvalumab monotherapy or durvalumab + tremelimumab combination therapy as applicable, and who had a baseline tumor assessment prior to dosing).

DCR during the retreatment phase was defined as the percentage of patients who had a BoR of CR or PR in the first 3 months (PDAC patients) or 4 months (UBC and TNBC patients) or who had demonstrated SD for a minimum interval of 3 or 4 months following the start of study treatment. DCR was determined programmatically based on RECIST 1.1 using site Investigator data and all data up until the first progression event. 95% CIs were calculated using the Clopper Pearson method.

Outcome measures

Measure	UBC - Tremelimumab Monotherapy n=7 Participants Patients with UBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	TNBC - Tremelimumab Monotherapy n=5 Participants Patients with TNBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	PDAC - Tremelimumab Monotherapy n=4 Participants Patients with PDAC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	UBC- MEDI n=4 Participants Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.	PDAC - MEDI n=1 Participants Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
DCR During Retreatment Phase	28.6 Percentage of Patients Interval 3.67 to 70.96	20.0 Percentage of Patients Interval 0.51 to 71.64	25.0 Percentage of Patients Interval 0.63 to 80.59	25.0 Percentage of Patients Interval 0.63 to 80.59	0.0 Percentage of Patients Interval 0.0 to 97.5

SECONDARY outcome

Timeframe: From baseline to 12 months in retreatment phase

Population: Analysis was performed on the MEDI and COMBO analysis sets (all patients who were treated with tremelimumab, received at least 1 dose of durvalumab monotherapy or durvalumab + tremelimumab combination therapy as applicable, and who had a baseline tumor assessment prior to dosing).

PFS during the retreatment phase was assessed by the site Investigator using RECIST 1.1 and defined as the time from the date of enrollment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from therapy or received another anticancer therapy prior to progression.

Progression events that did not occur within 3 months (PDAC patients) or 4 months (UBC/TNBC patients) of the last evaluable assessment (or first dose) were censored. Median PFS was calculated using the Kaplan-Meier technique.

Outcome measures

Measure	UBC - Tremelimumab Monotherapy n=7 Participants Patients with UBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	TNBC - Tremelimumab Monotherapy n=5 Participants Patients with TNBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	PDAC - Tremelimumab Monotherapy n=4 Participants Patients with PDAC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	UBC- MEDI n=4 Participants Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.	PDAC - MEDI n=1 Participants Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
Median PFS During Retreatment Phase	2.83 Months Interval 1.81 to 3.65	0.99 Months Interval 0.92 to Upper limit was not estimable in this cohort.	2.86 Months Interval 1.87 to 3.52	2.86 Months Interval 1.81 to 6.62	1.84 Months Interval 1.84 to 1.84

SECONDARY outcome

Timeframe: From baseline to 12 months in retreatment phase

Population: Analysis was performed on the MEDI and COMBO analysis sets (all patients who were treated with tremelimumab, received at least 1 dose of durvalumab monotherapy or durvalumab + tremelimumab combination therapy as applicable, and who had a baseline tumor assessment prior to dosing).

BoR during the retreatment phase was calculated based on the overall visit responses from each RECIST 1.1 assessment and was defined as the best response a patient had during their time in the study (from CR, PR, SD, PD or NE) obtained among all tumor assessment visits from baseline until end of treatment or determination of PD. The BoR was summarized by percentage of patients for each category (CR, PR, SD, PD, and NE).

Outcome measures

Measure	UBC - Tremelimumab Monotherapy n=7 Participants Patients with UBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	TNBC - Tremelimumab Monotherapy n=5 Participants Patients with TNBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	PDAC - Tremelimumab Monotherapy n=4 Participants Patients with PDAC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	UBC- MEDI n=4 Participants Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.	PDAC - MEDI n=1 Participants Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
BoR During Retreatment Phase SD	14.3 Percentage of Patients	20.0 Percentage of Patients	0.0 Percentage of Patients	0.0 Percentage of Patients	0.0 Percentage of Patients
BoR During Retreatment Phase PD	71.4 Percentage of Patients	80.0 Percentage of Patients	100.0 Percentage of Patients	75.0 Percentage of Patients	100.0 Percentage of Patients
BoR During Retreatment Phase NE	14.3 Percentage of Patients	0.0 Percentage of Patients	0.0 Percentage of Patients	0.0 Percentage of Patients	0.0 Percentage of Patients
BoR During Retreatment Phase CR	0.0 Percentage of Patients	0.0 Percentage of Patients	0.0 Percentage of Patients	0.0 Percentage of Patients	0.0 Percentage of Patients
BoR During Retreatment Phase PR	0.0 Percentage of Patients	0.0 Percentage of Patients	0.0 Percentage of Patients	25.0 Percentage of Patients	0.0 Percentage of Patients

SECONDARY outcome

Timeframe: From baseline in retreatment phase to final data cut-off date

Population: Analysis was performed on the MEDI and COMBO analysis sets (all patients who were treated with tremelimumab, received at least 1 dose of durvalumab monotherapy or durvalumab + tremelimumab combination therapy as applicable, and who had a baseline tumor assessment prior to dosing).

OS during the retreatment phase was defined as the time from the date of first dose until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique.

Outcome measures

Measure	UBC - Tremelimumab Monotherapy n=7 Participants Patients with UBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	TNBC - Tremelimumab Monotherapy n=5 Participants Patients with TNBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	PDAC - Tremelimumab Monotherapy n=4 Participants Patients with PDAC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	UBC- MEDI n=4 Participants Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.	PDAC - MEDI n=1 Participants Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
Median OS During Retreatment Phase	11.86 Months Interval 5.91 to Median and upper limit was not estimable in this cohort.	33.05 Months Interval 9.69 to 33.05	7.18 Months Interval 3.98 to 18.76	16.53 Months Interval 7.56 to 32.39	4.14 Months Lower and upper limits were not estimable in this cohort.

Adverse Events

UBC- Tremelimumab Monotherapy

Serious events: 18 serious events

Other events: 30 other events

Deaths: 13 deaths

TNBC - Tremelimumab Monotherapy

Serious events: 4 serious events

Other events: 10 other events

Deaths: 4 deaths

PDAC- Tremelimumab Monotherapy

Serious events: 11 serious events

Other events: 19 other events

Deaths: 12 deaths

UBC - COMBO

Serious events: 3 serious events

Other events: 7 other events

Deaths: 4 deaths

TNBC - COMBO

Serious events: 2 serious events

Other events: 5 other events

Deaths: 2 deaths

PDAC - COMBO

Serious events: 3 serious events

Other events: 4 other events

Deaths: 4 deaths

UBC- MEDI

Serious events: 1 serious events

Other events: 4 other events

Deaths: 4 deaths

PDAC - MEDI

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Measure	UBC- Tremelimumab Monotherapy n=32 participants at risk Patients with UBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	TNBC - Tremelimumab Monotherapy n=12 participants at risk Patients with TNBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	PDAC- Tremelimumab Monotherapy n=20 participants at risk Patients with PDAC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	UBC - COMBO n=7 participants at risk Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.	TNBC - COMBO n=5 participants at risk Eligible TNBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.	PDAC - COMBO n=4 participants at risk Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.	UBC- MEDI n=4 participants at risk Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.	PDAC - MEDI n=1 participants at risk Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
Blood and lymphatic system disorders Anaemia	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Endocrine disorders Hypophysitis	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Gastrointestinal disorders Abdominal pain	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	5.0% 1/20 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Gastrointestinal disorders Autoimmune colitis	6.2% 2/32 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Gastrointestinal disorders Colitis	9.4% 3/32 • Number of events 3 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	5.0% 1/20 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Gastrointestinal disorders Diarrhoea	12.5% 4/32 • Number of events 4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	15.0% 3/20 • Number of events 3 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Gastrointestinal disorders Duodenal obstruction	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	5.0% 1/20 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Gastrointestinal disorders Enterocolitis	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Gastrointestinal disorders Impaired gastric emptying	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Gastrointestinal disorders Vomiting	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
General disorders Asthenia	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
General disorders Euthanasia	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	5.0% 1/20 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
General disorders Malaise	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
General disorders Pain	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
General disorders Pyrexia	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	5.0% 1/20 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Hepatobiliary disorders Bile duct obstruction	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	5.0% 1/20 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Hepatobiliary disorders Hepatotoxicity	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Hepatobiliary disorders Jaundice cholestatic	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Infections and infestations Bacteraemia	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	5.0% 1/20 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Infections and infestations Kidney infection	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Infections and infestations Meningitis aseptic	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Infections and infestations Peritonitis bacterial	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Infections and infestations Pneumonia	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Injury, poisoning and procedural complications Fall	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Injury, poisoning and procedural complications Femur fracture	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	5.0% 1/20 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Metabolism and nutrition disorders Decreased appetite	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	5.0% 1/20 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Metabolism and nutrition disorders Hypercalcaemia	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	16.7% 2/12 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Musculoskeletal and connective tissue disorders Back pain	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Nervous system disorders Dizziness	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Nervous system disorders Encephalopathy	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Nervous system disorders Neuritis	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	5.0% 1/20 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Psychiatric disorders Confusional state	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Psychiatric disorders Mental status changes	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Renal and urinary disorders Acute kidney injury	6.2% 2/32 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Renal and urinary disorders Haematuria	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Renal and urinary disorders Urinary retention	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	5.0% 1/20 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Vascular disorders Deep vein thrombosis	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).

Other adverse events

Measure	UBC- Tremelimumab Monotherapy n=32 participants at risk Patients with UBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	TNBC - Tremelimumab Monotherapy n=12 participants at risk Patients with TNBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	PDAC- Tremelimumab Monotherapy n=20 participants at risk Patients with PDAC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.	UBC - COMBO n=7 participants at risk Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.	TNBC - COMBO n=5 participants at risk Eligible TNBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.	PDAC - COMBO n=4 participants at risk Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.	UBC- MEDI n=4 participants at risk Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.	PDAC - MEDI n=1 participants at risk Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
Blood and lymphatic system disorders Anaemia	21.9% 7/32 • Number of events 9 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	10.0% 2/20 • Number of events 3 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	28.6% 2/7 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Ear and labyrinth disorders Ear discomfort	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Ear and labyrinth disorders Vertigo	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Endocrine disorders Hyperthyroidism	6.2% 2/32 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Endocrine disorders Hypothyroidism	9.4% 3/32 • Number of events 3 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Eye disorders Eyelid oedema	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Gastrointestinal disorders Abdominal discomfort	6.2% 2/32 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	16.7% 2/12 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Gastrointestinal disorders Abdominal distension	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	10.0% 2/20 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Gastrointestinal disorders Abdominal pain	12.5% 4/32 • Number of events 4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	16.7% 2/12 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	30.0% 6/20 • Number of events 6 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Gastrointestinal disorders Abdominal pain upper	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	16.7% 2/12 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	10.0% 2/20 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Gastrointestinal disorders Anal inflammation	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Gastrointestinal disorders Ascites	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	5.0% 1/20 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Gastrointestinal disorders Colitis	12.5% 4/32 • Number of events 4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Gastrointestinal disorders Constipation	28.1% 9/32 • Number of events 9 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	41.7% 5/12 • Number of events 5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	15.0% 3/20 • Number of events 3 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Gastrointestinal disorders Diarrhoea	25.0% 8/32 • Number of events 9 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	16.7% 2/12 • Number of events 3 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 4/20 • Number of events 7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Gastrointestinal disorders Dyspepsia	9.4% 3/32 • Number of events 4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	5.0% 1/20 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Gastrointestinal disorders Gastritis	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Gastrointestinal disorders Haematochezia	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Gastrointestinal disorders Nausea	34.4% 11/32 • Number of events 13 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 4/20 • Number of events 4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Gastrointestinal disorders Stomatitis	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Gastrointestinal disorders Vomiting	12.5% 4/32 • Number of events 5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	16.7% 2/12 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	10.0% 2/20 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 3 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	100.0% 1/1 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
General disorders Asthenia	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	5.0% 1/20 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	50.0% 2/4 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	100.0% 1/1 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
General disorders Face oedema	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
General disorders Fatigue	46.9% 15/32 • Number of events 20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	30.0% 6/20 • Number of events 6 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	28.6% 2/7 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
General disorders Influenza like illness	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
General disorders Malaise	6.2% 2/32 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
General disorders Non-cardiac chest pain	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
General disorders Oedema	6.2% 2/32 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
General disorders Oedema peripheral	12.5% 4/32 • Number of events 4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	10.0% 2/20 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
General disorders Pyrexia	12.5% 4/32 • Number of events 4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	16.7% 2/12 • Number of events 3 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	10.0% 2/20 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	28.6% 2/7 • Number of events 3 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Infections and infestations Catheter site infection	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Infections and infestations Oral infection	6.2% 2/32 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Infections and infestations Paronychia	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Infections and infestations Pneumonia	6.2% 2/32 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Infections and infestations Rhinitis	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Infections and infestations Urinary tract infection	12.5% 4/32 • Number of events 4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	16.7% 2/12 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Infections and infestations Wound infection	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Injury, poisoning and procedural complications Procedural pain	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Injury, poisoning and procedural complications Radiation skin injury	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Investigations Alanine aminotransferase increased	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	15.0% 3/20 • Number of events 3 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Investigations Amylase increased	6.2% 2/32 • Number of events 4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Investigations Aspartate aminotransferase increased	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	10.0% 2/20 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Investigations Blood creatinine increased	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	5.0% 1/20 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Investigations Gamma-glutamyltransferase increased	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	10.0% 2/20 • Number of events 3 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Investigations Lipase increased	9.4% 3/32 • Number of events 4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Investigations Weight decreased	12.5% 4/32 • Number of events 4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	10.0% 2/20 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	40.0% 2/5 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Metabolism and nutrition disorders Decreased appetite	21.9% 7/32 • Number of events 9 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	16.7% 2/12 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 5/20 • Number of events 5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	80.0% 4/5 • Number of events 4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Metabolism and nutrition disorders Dehydration	12.5% 4/32 • Number of events 4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Metabolism and nutrition disorders Hyperglycaemia	18.8% 6/32 • Number of events 6 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	5.0% 1/20 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Metabolism and nutrition disorders Hyperkalaemia	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Metabolism and nutrition disorders Hypoalbuminaemia	6.2% 2/32 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	5.0% 1/20 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Metabolism and nutrition disorders Hypocalcaemia	6.2% 2/32 • Number of events 3 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	5.0% 1/20 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Metabolism and nutrition disorders Hypokalaemia	15.6% 5/32 • Number of events 7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	5.0% 1/20 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 3 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Metabolism and nutrition disorders Hypomagnesaemia	9.4% 3/32 • Number of events 4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Metabolism and nutrition disorders Hyponatraemia	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	16.7% 2/12 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	15.0% 3/20 • Number of events 3 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	40.0% 2/5 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	50.0% 2/4 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Musculoskeletal and connective tissue disorders Arthralgia	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Musculoskeletal and connective tissue disorders Back pain	12.5% 4/32 • Number of events 5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	15.0% 3/20 • Number of events 3 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Musculoskeletal and connective tissue disorders Muscular weakness	9.4% 3/32 • Number of events 3 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	5.0% 1/20 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Musculoskeletal and connective tissue disorders Myalgia	6.2% 2/32 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Nervous system disorders Brain oedema	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Nervous system disorders Dizziness	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	100.0% 1/1 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Nervous system disorders Facial paralysis	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Nervous system disorders Headache	9.4% 3/32 • Number of events 3 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	16.7% 2/12 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Nervous system disorders Peripheral sensory neuropathy	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Nervous system disorders Presyncope	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Psychiatric disorders Confusional state	6.2% 2/32 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Psychiatric disorders Delirium	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Psychiatric disorders Depressed mood	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	5.0% 1/20 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Psychiatric disorders Depression	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	10.0% 2/20 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Psychiatric disorders Insomnia	9.4% 3/32 • Number of events 3 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	16.7% 2/12 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Renal and urinary disorders Acute kidney injury	6.2% 2/32 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Renal and urinary disorders Bladder spasm	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Renal and urinary disorders Dysuria	3.1% 1/32 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Renal and urinary disorders Haematuria	9.4% 3/32 • Number of events 3 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Renal and urinary disorders Urinary tract pain	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Respiratory, thoracic and mediastinal disorders Cough	25.0% 8/32 • Number of events 9 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	5.0% 1/20 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	40.0% 2/5 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Respiratory, thoracic and mediastinal disorders Dysphonia	3.1% 1/32 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.5% 4/32 • Number of events 5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Respiratory, thoracic and mediastinal disorders Laryngospasm	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 3/12 • Number of events 3 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	5.0% 1/20 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 3 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	16.7% 2/12 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	60.0% 3/5 • Number of events 3 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	5.0% 1/20 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Skin and subcutaneous tissue disorders Blister	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Skin and subcutaneous tissue disorders Dry skin	15.6% 5/32 • Number of events 5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	5.0% 1/20 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Skin and subcutaneous tissue disorders Nail discolouration	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Skin and subcutaneous tissue disorders Papule	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Skin and subcutaneous tissue disorders Pruritus	25.0% 8/32 • Number of events 9 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	41.7% 5/12 • Number of events 5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	35.0% 7/20 • Number of events 7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	40.0% 2/5 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Skin and subcutaneous tissue disorders Pruritus generalised	6.2% 2/32 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Skin and subcutaneous tissue disorders Rash	6.2% 2/32 • Number of events 3 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	16.7% 2/12 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 5/20 • Number of events 6 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	20.0% 1/5 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Skin and subcutaneous tissue disorders Rash maculo-papular	6.2% 2/32 • Number of events 3 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Vascular disorders Embolism	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Vascular disorders Hot flush	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Vascular disorders Hypertension	6.2% 2/32 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Vascular disorders Hypotension	6.2% 2/32 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	40.0% 2/5 • Number of events 2 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Vascular disorders Lymphoedema	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	8.3% 1/12 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Vascular disorders Vascular fragility	0.00% 0/32 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/12 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/20 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/7 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/5 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/4 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).	0.00% 0/1 • Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).

Additional Information

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AstraZeneca

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Restriction type: OTHER