Trial Outcomes & Findings for Lapatinib and Bevacizumab for Metastatic Breast Cancer (NCT NCT00444535)

Last Updated: 2021-10-25

Results Overview

The PFS rate is defined as the percentage of subjects who have shown no evidence of disease progression or death from any cause following 12 weeks of treatment. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Since there is no independent reviewer, only the investigator response was reported.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

52 participants

Primary outcome timeframe

up to week 12

Results posted on

2021-10-25

Participant Flow

Participant milestones

Participant milestones
Measure	Lapatinib + Bevacizumab Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously \[IV\] every two weeks)
Overall Study STARTED	52
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Lapatinib + Bevacizumab Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously \[IV\] every two weeks)
Overall Study Withdrawal by Subject	5
Overall Study Physician Decision	5
Overall Study progressive disease	1
Overall Study Adverse Event	2

Baseline Characteristics

Lapatinib and Bevacizumab for Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lapatinib + Bevacizumab n=52 Participants Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously \[IV\] every two weeks)
Age, Continuous	52.5 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized White/Caucasian/European Heritage	42 Participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	7 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian and White	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to week 12

Population: Intent-to-Treat (ITT) Population: all enrolled participants, regardless of whether or not they received any study medication

Outcome measures

Outcome measures
Measure	Lapatinib + Bevacizumab n=52 Participants Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously \[IV\] every two weeks)
Investigator-evaluated Crude Progression-free Survival Rate After 12 Weeks of Study Treatment No disease progression by Week 12	36 Participants
Investigator-evaluated Crude Progression-free Survival Rate After 12 Weeks of Study Treatment Disease progression or death by Week 12	16 Participants

SECONDARY outcome

Timeframe: This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years.

Population: ITT Population

Overall Tumor Response - Best Response per Investigator Assessment Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by image including CT, MRI or bone scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. For each subject, the best tumor response during the study was considered to be the 'Overall Tumor Response' per the Response Evaluation Criteria in Solid Tumors (RECIST).

Outcome measures

Outcome measures
Measure	Lapatinib + Bevacizumab n=52 Participants Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously \[IV\] every two weeks)
Overall Tumor Response - Best Response Per Investigator Assessment (RECIST) Complete response	0 Participants
Overall Tumor Response - Best Response Per Investigator Assessment (RECIST) Partial response	7 Participants
Overall Tumor Response - Best Response Per Investigator Assessment (RECIST) Stable disease	26 Participants
Overall Tumor Response - Best Response Per Investigator Assessment (RECIST) Progressive Disease	11 Participants
Overall Tumor Response - Best Response Per Investigator Assessment (RECIST) Unknown	8 Participants

SECONDARY outcome

Population: ITT Population.

Overall Tumor Response Rate is defined as the percentage of subjects achieving either a confirmed complete (CR) or partial (PR) tumor response by investigator and per the Response Evaluation Criteria in Solid Tumors (RECIST). For each subject, the best tumor response during the study are considered the 'Overall Tumor Response.' Subjects with unknown or missing response are treated as non-responders; i.e. they are included in the denominator when calculating the percentage.

Outcome measures

Outcome measures
Measure	Lapatinib + Bevacizumab n=52 Participants Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously \[IV\] every two weeks)
Overall Tumor Response Rate Per Investigator Assessment (RECIST)	13.5 Percentage of participants Interval 5.6 to 25.8

SECONDARY outcome

Population: ITT Population.

Clinical Benefit Rate is defined as the percentage of subjects with evidence of confirmed complete or partial tumor responses at any time or stable disease for at least 24 weeks per the Response Evaluation Criteria in Solid Tumors (RECIST). Subjects with unknown or missing response are treated as non-responders (i.e. not Complete response (CR), Partial response (PR) or Stable Disease (SD)).

Outcome measures

Outcome measures
Measure	Lapatinib + Bevacizumab n=52 Participants Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously \[IV\] every two weeks)
Investigator-Assessed Clinical Benefit Response Rate (%) (RECIST)	38.5 Percentage of participants Interval 15.4 to 59.2

SECONDARY outcome

Population: ITT Population

Progression-free survival (PFS) = time from treatment start date until the first documented sign of disease progression, as defined by the investigator, or death due to any cause. For participants who did not progress or die at the time of reporting, PFS data were censored at the time of the last radiological assessment.

Outcome measures

Outcome measures
Measure	Lapatinib + Bevacizumab n=52 Participants Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously \[IV\] every two weeks)
Progression-free Survival Progressed or Died (event)	39 Participants
Progression-free Survival Censored, Follow-up ended	13 Participants

SECONDARY outcome

Population: ITT Population

Outcome measures

Outcome measures
Measure	Lapatinib + Bevacizumab n=52 Participants Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously \[IV\] every two weeks)
Progression-free Survival - Kaplan-Meier Estimates for Progression-free Survival (Weeks) - Median	24.7 weeks Interval 20.9 to 33.1

SECONDARY outcome

Population: ITT Population

Outcome measures

Outcome measures
Measure	Lapatinib + Bevacizumab n=52 Participants Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously \[IV\] every two weeks)
Progression-free Survival - Kaplan-Meier Estimates for Progression-free Survival (Weeks) - 1st and 3rd Quartile Estimates for progression-free survival 1st Quartile (weeks)	12.9 weeks Interval 6.1 to 21.4
Progression-free Survival - Kaplan-Meier Estimates for Progression-free Survival (Weeks) - 1st and 3rd Quartile Estimates for progression-free survival 3rd Quartile (weeks)	35.6 weeks Interval 31.1 to 61.3

Adverse Events

Lapatinib + Bevacizumab

Serious events: 13 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lapatinib + Bevacizumab n=52 participants at risk Lapatinib + Bevacizumab
Blood and lymphatic system disorders Anaemia	1.9% 1/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Blood and lymphatic system disorders Blood loss anaemia	1.9% 1/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Cardiac disorders Left ventricular dysfunction	1.9% 1/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Gastrointestinal disorders Abdominal pain	5.8% 3/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Gastrointestinal disorders Abdominal pain upper	1.9% 1/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Gastrointestinal disorders Diarrhoea	5.8% 3/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Gastrointestinal disorders Gastric haemorrhage	1.9% 1/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Gastrointestinal disorders Gastritis	1.9% 1/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Gastrointestinal disorders Lower gastrointestinal haemorrhage	1.9% 1/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Gastrointestinal disorders Nausea	1.9% 1/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Gastrointestinal disorders Vomiting	3.8% 2/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
General disorders Pyrexia	1.9% 1/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Infections and infestations Viral upper respiratory tract infection	1.9% 1/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Investigations Ejection fraction decreased	5.8% 3/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Metabolism and nutrition disorders Dehydration	3.8% 2/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Renal and urinary disorders Hydronephrosis	1.9% 1/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Respiratory, thoracic and mediastinal disorders Bronchiectasis	1.9% 1/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.9% 1/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Respiratory, thoracic and mediastinal disorders Haemoptysis	1.9% 1/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Skin and subcutaneous tissue disorders Rash	1.9% 1/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Vascular disorders Deep vein thrombosis	1.9% 1/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Vascular disorders Hypotension	1.9% 1/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).

Other adverse events

Other adverse events
Measure	Lapatinib + Bevacizumab n=52 participants at risk Lapatinib + Bevacizumab
Eye disorders Vision blurred	7.7% 4/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Gastrointestinal disorders Abdominal distension	7.7% 4/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Gastrointestinal disorders Abdominal pain	13.5% 7/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Gastrointestinal disorders Abdominal pain upper	7.7% 4/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Gastrointestinal disorders Constipation	19.2% 10/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Gastrointestinal disorders Diarrhoea	78.8% 41/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Gastrointestinal disorders Dry mouth	9.6% 5/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Gastrointestinal disorders Dyspepsia	7.7% 4/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Gastrointestinal disorders Gingival bleeding	5.8% 3/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Gastrointestinal disorders Haemorrhoidal haemorrhage	5.8% 3/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Gastrointestinal disorders Haemorrhoids	7.7% 4/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Gastrointestinal disorders Mouth ulceration	7.7% 4/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Gastrointestinal disorders Nausea	48.1% 25/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Gastrointestinal disorders Vomiting	32.7% 17/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
General disorders Asthenia	5.8% 3/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
General disorders Chills	5.8% 3/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
General disorders Fatigue	61.5% 32/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
General disorders Mucosal inflammation	19.2% 10/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
General disorders Pain	5.8% 3/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
General disorders Pyrexia	5.8% 3/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Infections and infestations Nasopharyngitis	5.8% 3/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Infections and infestations Sinusitis	7.7% 4/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Infections and infestations Upper respiratory tract infection	11.5% 6/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Infections and infestations Urinary tract infection	7.7% 4/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Injury, poisoning and procedural complications Contusion	5.8% 3/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Injury, poisoning and procedural complications Fall	5.8% 3/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Investigations Alanine aminotransferase increased	7.7% 4/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Investigations Aspartate aminotransferase increased	5.8% 3/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Investigations Blood alkaline phosphatase increased	5.8% 3/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Investigations Weight decreased	11.5% 6/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Metabolism and nutrition disorders Decreased appetite	13.5% 7/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Musculoskeletal and connective tissue disorders Arthralgia	23.1% 12/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Musculoskeletal and connective tissue disorders Back pain	19.2% 10/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Musculoskeletal and connective tissue disorders Bone pain	7.7% 4/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Musculoskeletal and connective tissue disorders Muscle spasms	9.6% 5/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	13.5% 7/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	13.5% 7/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Musculoskeletal and connective tissue disorders Myalgia	13.5% 7/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Musculoskeletal and connective tissue disorders Neck pain	5.8% 3/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Musculoskeletal and connective tissue disorders Pain in extremity	11.5% 6/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Nervous system disorders Dizziness	5.8% 3/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Nervous system disorders Headache	46.2% 24/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Nervous system disorders Memory impairment	5.8% 3/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Nervous system disorders Neuropathy peripheral	5.8% 3/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Nervous system disorders Paraesthesia	5.8% 3/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Nervous system disorders Peripheral sensory neuropathy	9.6% 5/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Psychiatric disorders Anxiety	11.5% 6/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Psychiatric disorders Depression	9.6% 5/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Psychiatric disorders Insomnia	11.5% 6/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Renal and urinary disorders Proteinuria	11.5% 6/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Reproductive system and breast disorders Vulvovaginal dryness	5.8% 3/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Respiratory, thoracic and mediastinal disorders Cough	25.0% 13/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Respiratory, thoracic and mediastinal disorders Dysphonia	7.7% 4/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Respiratory, thoracic and mediastinal disorders Dyspnoea	15.4% 8/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	9.6% 5/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Respiratory, thoracic and mediastinal disorders Epistaxis	40.4% 21/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Respiratory, thoracic and mediastinal disorders Nasal congestion	9.6% 5/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Respiratory, thoracic and mediastinal disorders Nasal dryness	5.8% 3/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.8% 3/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	11.5% 6/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	5.8% 3/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Skin and subcutaneous tissue disorders Alopecia	7.7% 4/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Skin and subcutaneous tissue disorders Dry skin	11.5% 6/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Skin and subcutaneous tissue disorders Nail disorder	11.5% 6/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Skin and subcutaneous tissue disorders Pruritus	9.6% 5/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Skin and subcutaneous tissue disorders Rash	61.5% 32/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).
Vascular disorders Hypertension	25.0% 13/52 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).

Additional Information

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