Trial Outcomes & Findings for An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma (NCT NCT02213926)

Last Updated: 2026-02-10

Results Overview

The overall response rate (ORR) is defined as the proportion of subjects achieving either a partial remission (response) (PR) or complete response (CR) according to the Lugano Classification for NHL (Cheson 2014) as assessed by investigators, where SD stands for Stable Disease, PD for Progressive Disease and NE for Not Evaluable.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

124 participants

Primary outcome timeframe

From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months. 1 cycle =28 days

Results posted on

2026-02-10

Participant Flow

For the ACE-LY-004 program, Study Terminated by Sponsor refers to the following: Patients receiving treatment benefits will continue to be provided with study medication in the Post Final Analysis Management of the trial. No further data collection for analysis and reporting will be completed after the final Analysis.

Participant milestones

Participant milestones
Measure	ACP-196 100 mg BID subjects with relapsed/refractory MCL
Overall Study STARTED	124
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	124

Reasons for withdrawal

Reasons for withdrawal
Measure	ACP-196 100 mg BID subjects with relapsed/refractory MCL
Overall Study Death	59
Overall Study Withdrawal by Subject	10
Overall Study study terminated by sponsor	51
Overall Study Lost to Follow-up	3
Overall Study SITE CLOSURE - PI RETIREMENT	1

Baseline Characteristics

An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ACP-196 100 mg BID n=124 Participants subjects with relapsed/refractory MCL
Age, Continuous	67.1 Years STANDARD_DEVIATION 10.5 • n=4 Participants
Sex: Female, Male Female	25 Participants n=4 Participants
Sex: Female, Male Male	99 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic or Latino	4 Participants n=4 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	90 Participants n=4 Participants
Race/Ethnicity, Customized Not Reported	29 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=4 Participants
Race/Ethnicity, Customized Asian	0 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants
Race/Ethnicity, Customized White	92 Participants n=4 Participants
Region of Enrollment Australia	2 Participants n=4 Participants
Region of Enrollment Belgium	2 Participants n=4 Participants
Region of Enrollment France	26 Participants n=4 Participants
Region of Enrollment Italy	8 Participants n=4 Participants
Region of Enrollment Netherlands	5 Participants n=4 Participants
Region of Enrollment Poland	19 Participants n=4 Participants
Region of Enrollment Spain	4 Participants n=4 Participants
Region of Enrollment United Kingdom	13 Participants n=4 Participants
Region of Enrollment USA	45 Participants n=4 Participants

PRIMARY outcome

Timeframe: From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months. 1 cycle =28 days

Population: The analysis population included all treated subjects.

Outcome measures

Outcome measures
Measure	ACP-196 (Acalabrutinib) n=124 Participants ACP-196 (acalabrutinib) 100 mg BID
Overall Response Rate (ORR) of ACP-196 (Acalabrutinib) in Subjects With Previously Treated MCL. CR	59 Participants
Overall Response Rate (ORR) of ACP-196 (Acalabrutinib) in Subjects With Previously Treated MCL. PR	42 Participants
Overall Response Rate (ORR) of ACP-196 (Acalabrutinib) in Subjects With Previously Treated MCL. SD	10 Participants
Overall Response Rate (ORR) of ACP-196 (Acalabrutinib) in Subjects With Previously Treated MCL. PD	10 Participants
Overall Response Rate (ORR) of ACP-196 (Acalabrutinib) in Subjects With Previously Treated MCL. NE	3 Participants

Adverse Events

ACP-196 100 mg BID

Serious events: 62 serious events

Other events: 122 other events

Deaths: 59 deaths

Serious adverse events

Serious adverse events
Measure	ACP-196 100 mg BID n=124 participants at risk Description (Arm-group)
Blood and lymphatic system disorders Anaemia	4.8% 6/124 • Number of events 9 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Blood and lymphatic system disorders Febrile neutropenia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Blood and lymphatic system disorders Haemolytic anaemia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Blood and lymphatic system disorders Leukostasis syndrome	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Cardiac disorders Acute coronary syndrome	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Cardiac disorders Acute myocardial infarction	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Cardiac disorders Cardiac failure	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Cardiac disorders Cardio-respiratory arrest	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Cardiac disorders Coronary artery disease	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Abdominal pain	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Colitis	1.6% 2/124 • Number of events 3 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Diarrhoea	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Inguinal hernia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Inguinal hernia strangulated	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Intestinal obstruction	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Nausea	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Pancreatitis acute	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Umbilical hernia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Vomiting	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
General disorders Chest pain	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
General disorders General physical health deterioration	3.2% 4/124 • Number of events 4 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
General disorders Non-cardiac chest pain	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
General disorders Peripheral swelling	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
General disorders Pyrexia	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Hepatobiliary disorders Cholecystitis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Hepatobiliary disorders Cholelithiasis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Hepatobiliary disorders Jaundice extrahepatic obstructive	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Arthritis bacterial	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Bacteraemia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Catheter site infection	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Clostridium difficile infection	0.81% 1/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Escherichia infection	0.81% 1/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Gastroenteritis viral	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Lower respiratory tract infection	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Lower respiratory tract infection bacterial	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Paronychia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Pharyngitis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Pneumonia	6.5% 8/124 • Number of events 8 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Pseudomonal bacteraemia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Respiratory syncytial virus infection	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Respiratory tract infection	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Sepsis	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Streptococcal bacteraemia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Upper respiratory tract infection	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Urinary tract infection	0.81% 1/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Urinary tract infection bacterial	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Urosepsis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Injury, poisoning and procedural complications Ankle fracture	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Injury, poisoning and procedural complications Fall	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Injury, poisoning and procedural complications Humerus fracture	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Injury, poisoning and procedural complications Incisional hernia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Injury, poisoning and procedural complications Radius fracture	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Injury, poisoning and procedural complications Subdural haematoma	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Injury, poisoning and procedural complications Tibia fracture	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Injury, poisoning and procedural complications Transfusion reaction	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Investigations General physical condition abnormal	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Metabolism and nutrition disorders Decreased appetite	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Metabolism and nutrition disorders Lactic acidosis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Metabolism and nutrition disorders Tumour lysis syndrome	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Musculoskeletal and connective tissue disorders Arthralgia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large b-cell lymphoma	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Nervous system disorders Autoimmune encephalopathy	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Nervous system disorders Headache	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Nervous system disorders Ischaemic stroke	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Psychiatric disorders Psychotic disorder	0.81% 1/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Psychiatric disorders Suicide attempt	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Renal and urinary disorders Haematuria	0.81% 1/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Renal and urinary disorders Hydronephrosis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Reproductive system and breast disorders Prostatitis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Skin and subcutaneous tissue disorders Acute febrile neutrophilic dermatosis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Vascular disorders Aortic stenosis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Vascular disorders Hypotension	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Vascular disorders Peripheral ischaemia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.

Other adverse events

Other adverse events
Measure	ACP-196 100 mg BID n=124 participants at risk Description (Arm-group)
Blood and lymphatic system disorders Anaemia	12.9% 16/124 • Number of events 25 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Blood and lymphatic system disorders Haemolysis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Blood and lymphatic system disorders Haemorrhagic diathesis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Blood and lymphatic system disorders Increased tendency to bruise	2.4% 3/124 • Number of events 3 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Blood and lymphatic system disorders Iron deficiency anaemia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Blood and lymphatic system disorders Leukocytosis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Blood and lymphatic system disorders Leukopenia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Blood and lymphatic system disorders Lymph node pain	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Blood and lymphatic system disorders Neutropenia	11.3% 14/124 • Number of events 18 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Blood and lymphatic system disorders Pancytopenia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Blood and lymphatic system disorders Splenomegaly	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Blood and lymphatic system disorders Thrombocytopenia	5.6% 7/124 • Number of events 11 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Cardiac disorders Angina pectoris	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Cardiac disorders Aortic valve incompetence	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Cardiac disorders Atrial fibrillation	2.4% 3/124 • Number of events 3 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Cardiac disorders Atrioventricular block complete	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Cardiac disorders Bradycardia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Cardiac disorders Extrasystoles	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Cardiac disorders Mitral valve incompetence	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Cardiac disorders Pericardial effusion	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Cardiac disorders Right ventricular enlargement	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Cardiac disorders Sinus arrest	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Cardiac disorders Sinus tachycardia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Cardiac disorders Tachycardia	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Cardiac disorders Tricuspid valve incompetence	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Cardiac disorders Ventricular extrasystoles	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Ear and labyrinth disorders Deafness	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Ear and labyrinth disorders Hypoacusis	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Ear and labyrinth disorders Otorrhoea	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Ear and labyrinth disorders Tinnitus	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Ear and labyrinth disorders Vertigo	3.2% 4/124 • Number of events 4 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Ear and labyrinth disorders Vertigo positional	1.6% 2/124 • Number of events 3 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Endocrine disorders Hyperparathyroidism	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Eye disorders Cataract	3.2% 4/124 • Number of events 5 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Eye disorders Chalazion	0.81% 1/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Eye disorders Conjunctival haemorrhage	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Eye disorders Dry eye	4.0% 5/124 • Number of events 7 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Eye disorders Eye discharge	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Eye disorders Eye pain	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Eye disorders Eye pruritus	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Eye disorders Eyelid rash	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Eye disorders Lacrimation increased	5.6% 7/124 • Number of events 13 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Eye disorders Ocular hyperaemia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Eye disorders Periorbital swelling	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Eye disorders Scleral hyperaemia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Eye disorders Vision blurred	6.5% 8/124 • Number of events 11 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Abdominal discomfort	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Abdominal distension	2.4% 3/124 • Number of events 3 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Abdominal pain	11.3% 14/124 • Number of events 21 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Abdominal pain lower	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Abdominal pain upper	8.1% 10/124 • Number of events 11 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Aerophagia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Constipation	16.1% 20/124 • Number of events 26 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Dental caries	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Diarrhoea	37.9% 47/124 • Number of events 76 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Dry mouth	2.4% 3/124 • Number of events 3 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Dyspepsia	2.4% 3/124 • Number of events 3 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Dysphagia	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Flatulence	2.4% 3/124 • Number of events 3 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Food poisoning	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Gastric ulcer	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Gastritis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Gastrointestinal mucosa hyperaemia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Gastrointestinal polyp	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Gastrointestinal sounds abnormal	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Gastrooesophageal reflux disease	4.0% 5/124 • Number of events 8 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Glossodynia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Haematochezia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Haemorrhoids	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Hiatus hernia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Hyperchlorhydria	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Inguinal hernia	2.4% 3/124 • Number of events 3 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Intestinal obstruction	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Irritable bowel syndrome	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Large intestine polyp	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Nausea	21.8% 27/124 • Number of events 49 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Odynophagia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Oesophageal spasm	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Oesophagitis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Oral pain	1.6% 2/124 • Number of events 4 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Proctalgia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Rectal haemorrhage	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Stomatitis	7.3% 9/124 • Number of events 17 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Tooth disorder	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Toothache	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Gastrointestinal disorders Vomiting	14.5% 18/124 • Number of events 30 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
General disorders Asthenia	17.7% 22/124 • Number of events 35 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
General disorders Chest discomfort	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
General disorders Chest pain	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
General disorders Chills	3.2% 4/124 • Number of events 4 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
General disorders Crepitations	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
General disorders Facial pain	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
General disorders Fatigue	29.8% 37/124 • Number of events 70 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
General disorders Gait disturbance	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
General disorders General physical health deterioration	2.4% 3/124 • Number of events 3 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
General disorders Influenza like illness	4.8% 6/124 • Number of events 10 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
General disorders Malaise	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
General disorders Nodule	1.6% 2/124 • Number of events 3 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
General disorders Non-cardiac chest pain	3.2% 4/124 • Number of events 4 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
General disorders Oedema	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
General disorders Oedema peripheral	8.9% 11/124 • Number of events 16 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
General disorders Pain	3.2% 4/124 • Number of events 4 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
General disorders Peripheral swelling	5.6% 7/124 • Number of events 8 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
General disorders Pyrexia	15.3% 19/124 • Number of events 26 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
General disorders Sensation of foreign body	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
General disorders Suprapubic pain	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
General disorders Swelling	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
General disorders Vessel puncture site haematoma	0.81% 1/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Hepatobiliary disorders Cholelithiasis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Hepatobiliary disorders Drug-induced liver injury	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Hepatobiliary disorders Hepatic steatosis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Hepatobiliary disorders Hepatotoxicity	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Immune system disorders Contrast media allergy	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Immune system disorders Food allergy	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Immune system disorders Hypersensitivity	0.81% 1/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Immune system disorders Hypogammaglobulinaemia	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Immune system disorders Seasonal allergy	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Acute sinusitis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Bronchitis	8.9% 11/124 • Number of events 12 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Bronchitis viral	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Catheter site infection	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Cellulitis	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Chronic sinusitis	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Clostridium difficile infection	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Conjunctivitis	3.2% 4/124 • Number of events 4 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Cystitis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Cytomegalovirus viraemia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Dacryocystitis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Dermatitis infected	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Ear infection	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Erysipelas	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Eye infection	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Fungal infection	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Fungal skin infection	0.81% 1/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Furuncle	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Gastroenteritis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Gastrointestinal infection	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Gastrointestinal viral infection	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Helicobacter gastritis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Herpes dermatitis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Herpes simplex	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Herpes zoster	8.1% 10/124 • Number of events 10 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Infection	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Influenza	5.6% 7/124 • Number of events 7 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Jc virus infection	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Laryngitis	3.2% 4/124 • Number of events 5 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Localised infection	2.4% 3/124 • Number of events 3 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Lower respiratory tract infection	4.8% 6/124 • Number of events 13 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Lower respiratory tract infection bacterial	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Mastoiditis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Nasopharyngitis	8.1% 10/124 • Number of events 14 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Ophthalmic herpes zoster	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Oral herpes	2.4% 3/124 • Number of events 3 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Otitis externa	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Otosalpingitis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Parainfluenzae virus infection	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Peripheral nerve infection	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Pharyngitis	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Pneumocystis jirovecii pneumonia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Pneumonia	6.5% 8/124 • Number of events 9 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Pulpitis dental	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Respiratory tract infection	2.4% 3/124 • Number of events 3 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Rhinitis	4.8% 6/124 • Number of events 6 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Rhinovirus infection	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Sinusitis	12.9% 16/124 • Number of events 25 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Skin infection	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Streptococcal bacteraemia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Tonsillitis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Tracheitis	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Upper respiratory tract infection	16.1% 20/124 • Number of events 30 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Urinary tract infection	4.0% 5/124 • Number of events 13 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Vascular device infection	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Viral infection	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Infections and infestations Viral upper respiratory tract infection	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Injury, poisoning and procedural complications Anaemia postoperative	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Injury, poisoning and procedural complications Animal bite	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Injury, poisoning and procedural complications Arthropod bite	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Injury, poisoning and procedural complications Contusion	12.9% 16/124 • Number of events 23 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Injury, poisoning and procedural complications Fall	4.8% 6/124 • Number of events 6 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Injury, poisoning and procedural complications Hand fracture	0.81% 1/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Injury, poisoning and procedural complications Head injury	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Injury, poisoning and procedural complications Infusion related reaction	2.4% 3/124 • Number of events 3 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Injury, poisoning and procedural complications Ligament sprain	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Injury, poisoning and procedural complications Muscle strain	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Injury, poisoning and procedural complications Periorbital haematoma	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Injury, poisoning and procedural complications Procedural pain	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Injury, poisoning and procedural complications Radius fracture	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Injury, poisoning and procedural complications Skin abrasion	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Injury, poisoning and procedural complications Skin laceration	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Injury, poisoning and procedural complications Tendon rupture	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Injury, poisoning and procedural complications Tibia fracture	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Injury, poisoning and procedural complications Tooth fracture	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Injury, poisoning and procedural complications Vaccination complication	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Injury, poisoning and procedural complications Wound	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Investigations Alanine aminotransferase increased	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Investigations Blood bilirubin increased	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Investigations Blood cholesterol increased	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Investigations Blood creatinine increased	2.4% 3/124 • Number of events 5 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Investigations Blood iron decreased	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Investigations Blood pressure increased	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Investigations Blood urea increased	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Investigations Breath sounds abnormal	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Investigations Neutrophil count decreased	3.2% 4/124 • Number of events 5 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Investigations Platelet count decreased	2.4% 3/124 • Number of events 3 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Investigations Serum ferritin decreased	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Investigations Thyroxine decreased	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Investigations Transaminases increased	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Investigations Weight decreased	3.2% 4/124 • Number of events 6 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Investigations Weight increased	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Metabolism and nutrition disorders Decreased appetite	6.5% 8/124 • Number of events 12 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Metabolism and nutrition disorders Dehydration	2.4% 3/124 • Number of events 4 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Metabolism and nutrition disorders Hypercalcaemia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Metabolism and nutrition disorders Hyperkalaemia	4.0% 5/124 • Number of events 6 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Metabolism and nutrition disorders Hyperuricaemia	4.0% 5/124 • Number of events 6 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Metabolism and nutrition disorders Hypocalcaemia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Metabolism and nutrition disorders Hypokalaemia	4.8% 6/124 • Number of events 8 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Metabolism and nutrition disorders Hypomagnesaemia	3.2% 4/124 • Number of events 4 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Metabolism and nutrition disorders Hyponatraemia	1.6% 2/124 • Number of events 4 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Metabolism and nutrition disorders Hypophosphataemia	0.81% 1/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Metabolism and nutrition disorders Iron deficiency	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Vascular disorders Lymphoedema	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Metabolism and nutrition disorders Tumour lysis syndrome	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Metabolism and nutrition disorders Vitamin b12 deficiency	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Musculoskeletal and connective tissue disorders Arthralgia	10.5% 13/124 • Number of events 16 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Musculoskeletal and connective tissue disorders Back pain	11.3% 14/124 • Number of events 15 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Musculoskeletal and connective tissue disorders Bone pain	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Musculoskeletal and connective tissue disorders Flank pain	2.4% 3/124 • Number of events 3 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Musculoskeletal and connective tissue disorders Groin pain	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Musculoskeletal and connective tissue disorders Joint swelling	2.4% 3/124 • Number of events 3 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Musculoskeletal and connective tissue disorders Limb discomfort	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Musculoskeletal and connective tissue disorders Muscle contracture	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Musculoskeletal and connective tissue disorders Muscle spasms	7.3% 9/124 • Number of events 12 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Musculoskeletal and connective tissue disorders Muscular weakness	2.4% 3/124 • Number of events 3 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	2.4% 3/124 • Number of events 3 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	8.9% 11/124 • Number of events 11 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Musculoskeletal and connective tissue disorders Myalgia	21.8% 27/124 • Number of events 49 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Musculoskeletal and connective tissue disorders Neck pain	3.2% 4/124 • Number of events 4 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Musculoskeletal and connective tissue disorders Osteoporosis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Musculoskeletal and connective tissue disorders Pain in extremity	6.5% 8/124 • Number of events 9 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Musculoskeletal and connective tissue disorders Tendon pain	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	4.0% 5/124 • Number of events 6 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of skin	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	1.6% 2/124 • Number of events 3 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour ulceration	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Nervous system disorders Aphasia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Nervous system disorders Balance disorder	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Nervous system disorders Burning sensation	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Nervous system disorders Carotid arteriosclerosis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Nervous system disorders Carotid artery stenosis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Nervous system disorders Disturbance in attention	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Nervous system disorders Dizziness	14.5% 18/124 • Number of events 21 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Nervous system disorders Dizziness postural	0.81% 1/124 • Number of events 3 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Nervous system disorders Dysgeusia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Nervous system disorders Encephalopathy	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Nervous system disorders Headache	38.7% 48/124 • Number of events 60 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Nervous system disorders Hypoaesthesia	5.6% 7/124 • Number of events 9 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Nervous system disorders Intention tremor	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Nervous system disorders Memory impairment	7.3% 9/124 • Number of events 12 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Nervous system disorders Migraine	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Nervous system disorders Neuralgia	2.4% 3/124 • Number of events 4 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Nervous system disorders Neuropathy peripheral	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Nervous system disorders Paraesthesia	8.1% 10/124 • Number of events 11 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Nervous system disorders Peripheral sensory neuropathy	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Nervous system disorders Presyncope	2.4% 3/124 • Number of events 3 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Nervous system disorders Resting tremor	0.81% 1/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Nervous system disorders Sciatica	3.2% 4/124 • Number of events 4 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Nervous system disorders Sensory loss	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Nervous system disorders Somnolence	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Nervous system disorders Syncope	4.0% 5/124 • Number of events 5 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Nervous system disorders Tremor	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Product Issues Device occlusion	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Psychiatric disorders Confusional state	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Psychiatric disorders Delirium	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Psychiatric disorders Depression	3.2% 4/124 • Number of events 4 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Psychiatric disorders Insomnia	7.3% 9/124 • Number of events 9 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Psychiatric disorders Mental status changes	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Psychiatric disorders Sleep disorder	3.2% 4/124 • Number of events 4 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Renal and urinary disorders Acute kidney injury	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Renal and urinary disorders Bladder spasm	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Renal and urinary disorders Dysuria	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Renal and urinary disorders Haematuria	1.6% 2/124 • Number of events 4 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Renal and urinary disorders Pollakiuria	3.2% 4/124 • Number of events 4 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Renal and urinary disorders Renal failure	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Renal and urinary disorders Renal injury	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Renal and urinary disorders Strangury	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Renal and urinary disorders Urinary incontinence	0.81% 1/124 • Number of events 3 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Renal and urinary disorders Urinary retention	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Reproductive system and breast disorders Adnexa uteri pain	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Reproductive system and breast disorders Pelvic pain	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Reproductive system and breast disorders Prostatitis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Bronchostenosis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Catarrh	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Cough	23.4% 29/124 • Number of events 38 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Dysphonia	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea	14.5% 18/124 • Number of events 26 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	4.0% 5/124 • Number of events 5 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Emphysema	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Epistaxis	7.3% 9/124 • Number of events 9 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Middle lobe syndrome	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.0% 5/124 • Number of events 6 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.0% 5/124 • Number of events 8 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Paranasal sinus discomfort	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Paranasal sinus hypersecretion	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Pharyngeal erythema	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.2% 4/124 • Number of events 4 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Productive cough	4.0% 5/124 • Number of events 10 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Pulmonary air leakage	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Rales	1.6% 2/124 • Number of events 4 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	4.8% 6/124 • Number of events 8 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Sinus pain	0.81% 1/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Sneezing	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Sputum discoloured	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract congestion	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	2.4% 3/124 • Number of events 3 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Respiratory, thoracic and mediastinal disorders Wheezing	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Skin and subcutaneous tissue disorders Actinic keratosis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Skin and subcutaneous tissue disorders Alopecia	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Skin and subcutaneous tissue disorders Blood blister	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Skin and subcutaneous tissue disorders Dermatitis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Skin and subcutaneous tissue disorders Dermatitis contact	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Skin and subcutaneous tissue disorders Drug eruption	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Skin and subcutaneous tissue disorders Dry skin	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Skin and subcutaneous tissue disorders Ecchymosis	3.2% 4/124 • Number of events 5 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Skin and subcutaneous tissue disorders Eczema	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Skin and subcutaneous tissue disorders Erythema	5.6% 7/124 • Number of events 7 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Skin and subcutaneous tissue disorders Hyperhidrosis	3.2% 4/124 • Number of events 4 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Skin and subcutaneous tissue disorders Intertrigo	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Skin and subcutaneous tissue disorders Night sweats	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Skin and subcutaneous tissue disorders Perioral dermatitis	0.81% 1/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Skin and subcutaneous tissue disorders Petechiae	8.9% 11/124 • Number of events 14 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Skin and subcutaneous tissue disorders Pruritus	4.8% 6/124 • Number of events 6 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Skin and subcutaneous tissue disorders Purpura	4.8% 6/124 • Number of events 7 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Skin and subcutaneous tissue disorders Rash	14.5% 18/124 • Number of events 31 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Skin and subcutaneous tissue disorders Rash erythematous	3.2% 4/124 • Number of events 4 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Skin and subcutaneous tissue disorders Rash papular	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Skin and subcutaneous tissue disorders Rash pruritic	1.6% 2/124 • Number of events 3 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Skin and subcutaneous tissue disorders Skin exfoliation	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Skin and subcutaneous tissue disorders Skin lesion	2.4% 3/124 • Number of events 4 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Skin and subcutaneous tissue disorders Stasis dermatitis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Skin and subcutaneous tissue disorders Urticaria	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Vascular disorders Aortic stenosis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Vascular disorders Arterial disorder	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Vascular disorders Deep vein thrombosis	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Vascular disorders Flushing	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Vascular disorders Haematoma	6.5% 8/124 • Number of events 8 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Vascular disorders Hot flush	1.6% 2/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Vascular disorders Hypertension	3.2% 4/124 • Number of events 5 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Vascular disorders Hypotension	4.8% 6/124 • Number of events 6 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Vascular disorders Peripheral arterial occlusive disease	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Vascular disorders Peripheral artery aneurysm	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Vascular disorders Peripheral venous disease	0.81% 1/124 • Number of events 2 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Vascular disorders Thrombophlebitis superficial	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Vascular disorders Thrombosed varicose vein	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Vascular disorders Varicose vein	0.81% 1/124 • Number of events 1 • From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.

Additional Information

Global Clinical Lead

AstraZeneca Clinical -Study Information Center

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place