Trial Outcomes & Findings for A Study of Tarceva (Erlotinib) as First Line Therapy in Participants With Non-Small Cell Lung Cancer Harbouring Epidermal Growth Factor Receptor (EGFR) Mutations (NCT NCT01310036)
NCT ID: NCT01310036
Last Updated: 2018-09-12
Results Overview
PFS1 was defined as time from first dose until documented progressive disease (PD), assessed per Response Evaluation Criteria in Solid Tumors RECIST, v. 1.1, or death from any cause, whichever occurred first. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
208 participants
Primary outcome timeframe
Approximately 68 months
Results posted on
2018-09-12
Participant Flow
Participant milestones
| Measure |
Erlotinib
Erlotinib 150 mg daily
|
|---|---|
|
Overall Study
STARTED
|
208
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
202
|
Reasons for withdrawal
| Measure |
Erlotinib
Erlotinib 150 mg daily
|
|---|---|
|
Overall Study
Administrative/other
|
10
|
|
Overall Study
Withdrew Consent
|
11
|
|
Overall Study
Refused Treatment/Did not Cooperate
|
4
|
|
Overall Study
Progression of Disease
|
164
|
|
Overall Study
Death
|
1
|
|
Overall Study
Adverse event or intercurrent illness
|
12
|
Baseline Characteristics
A Study of Tarceva (Erlotinib) as First Line Therapy in Participants With Non-Small Cell Lung Cancer Harbouring Epidermal Growth Factor Receptor (EGFR) Mutations
Baseline characteristics by cohort
| Measure |
Erlotinib
n=207 Participants
Erlotinib 150 mg daily
|
|---|---|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 11.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
129 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 68 monthsPopulation: The per protocol population included participants who had EGFR mutations confirmed by a study-designated central laboratory.
PFS1 was defined as time from first dose until documented progressive disease (PD), assessed per Response Evaluation Criteria in Solid Tumors RECIST, v. 1.1, or death from any cause, whichever occurred first. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.
Outcome measures
| Measure |
Erlotinib
n=148 Participants
Erlotinib 150 mg daily
|
|---|---|
|
Progression-free Survival Per RECIST, v. 1.1 (PFS1)
|
11.000 months
Interval 9.267 to 11.2
|
SECONDARY outcome
Timeframe: Approximately 68 monthsPopulation: The per protocol population included participants who had EGFR mutations confirmed by a study-designated central laboratory. Data are reported for evaluable participants.
PFS2 was defined as time from first study dose to off-erlotinib progressive disease (PD), assessed by the investigator based on overall clinical evaluation.
Outcome measures
| Measure |
Erlotinib
n=69 Participants
Erlotinib 150 mg daily
|
|---|---|
|
Progression-free Survival Per Investigator (PFS2)
|
15.000 months
Interval 13.067 to 18.7
|
SECONDARY outcome
Timeframe: Approximately 68 monthsPopulation: The per protocol population included participants who had EGFR mutations confirmed by a study-designated central laboratory. Data are reported for evaluable participants.
ORR was defined as the occurrence of either a confirmed complete (CR) or a partial response (PR, as a best overall response), as determined by RECIST, v. 1.1 criteria. CR was defined as disappearance of all target lesions. PR was defined as least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Erlotinib
n=148 Participants
Erlotinib 150 mg daily
|
|---|---|
|
Objective Response Rate (ORR) for All Participants and Participants With EGFR Mutation E19del or L858R
All Participants
|
72.3 percentage of participants
Interval 64.3 to 79.3
|
|
Objective Response Rate (ORR) for All Participants and Participants With EGFR Mutation E19del or L858R
EGFR Mutation E19del or L858R
|
72.9 percentage of participants
Interval 64.9 to 80.0
|
SECONDARY outcome
Timeframe: Approximately 68 monthsPopulation: The per protocol population included participants who had EGFR mutations confirmed by a study-designated central laboratory. Data are reported for evaluable participants.
DCR was defined as CR + PR + Stable disease (SD). CR was defined as disappearance of all target lesions. PR was defined as least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.
Outcome measures
| Measure |
Erlotinib
n=148 Participants
Erlotinib 150 mg daily
|
|---|---|
|
Disease Control Rate (DCR) for All Participants and Participants With EGFR Mutation E19del or L858R
All Participants
|
84.5 percentage of participants
Interval 77.6 to 89.9
|
|
Disease Control Rate (DCR) for All Participants and Participants With EGFR Mutation E19del or L858R
EGFR Mutation E19del or L858R
|
85.4 percentage of participants
Interval 78.6 to 90.7
|
SECONDARY outcome
Timeframe: Approximately 68 monthsPopulation: The per protocol population included participants who had EGFR mutations confirmed by a study-designated central laboratory. Data are reported for evaluable participants.
PFS1 was defined as time from first dose until documented progressive disease (PD), assessed per Response Evaluation Criteria in Solid Tumors RECIST, v. 1.1, or death from any cause, whichever occurred first. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.
Outcome measures
| Measure |
Erlotinib
n=144 Participants
Erlotinib 150 mg daily
|
|---|---|
|
Progression-free Survival for Participants With EGFR Mutation E19del or L858R Per RECIST, v. 1.1 (PFS1)
|
11.000 months
Interval 9.267 to 11.2
|
SECONDARY outcome
Timeframe: Approximately 68 monthsPopulation: The per protocol population included participants who had EGFR mutations confirmed by a study-designated central laboratory. Data are reported for evaluable participants.
OS was defined as the time from baseline to the date of death from any cause.
Outcome measures
| Measure |
Erlotinib
n=148 Participants
Erlotinib 150 mg daily
|
|---|---|
|
Overall Survival (OS) for All Participants and Participants With EGFR Mutation E19del or L858R
All Participants
|
31.633 months
Interval 28.1 to 36.133
|
|
Overall Survival (OS) for All Participants and Participants With EGFR Mutation E19del or L858R
EGFR Mutation E19del or L858R
|
31.800 months
Interval 28.1 to 36.133
|
SECONDARY outcome
Timeframe: Approximately 68 monthsPopulation: The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug.
Outcome measures
| Measure |
Erlotinib
n=207 Participants
Erlotinib 150 mg daily
|
|---|---|
|
Number of Participants With Adverse Events
|
206 participants
|
SECONDARY outcome
Timeframe: Approximately 68 monthsPopulation: Data were not collected.
This outcome measure was not assessed.
Outcome measures
Outcome data not reported
Adverse Events
Erlotinib
Serious events: 59 serious events
Other events: 206 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Erlotinib
n=207 participants at risk
Erlotinib 150 mg daily
|
|---|---|
|
Infections and infestations
Pneumonia
|
4.8%
10/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Infections and infestations
Cellulitis
|
0.97%
2/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Infections and infestations
Herpes zoster
|
0.97%
2/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Infections and infestations
Dengue fever
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Infections and infestations
Infection
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.97%
2/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Infections and infestations
Septic shock
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Infections and infestations
Staphylococcal scalded skin syndrome
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Infections and infestations
Urinary tract infection
|
0.97%
2/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
4/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.4%
3/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.4%
3/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Gastrointestinal disorders
Gastritis
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Gastrointestinal disorders
Ileus
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Pneumoconiosis
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
General disorders
Fatigue
|
0.97%
2/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
General disorders
Pyrexia
|
0.97%
2/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
General disorders
Death
|
0.97%
2/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Nervous system disorders
Cerebral infarction
|
0.97%
2/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Nervous system disorders
Seizure
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Nervous system disorders
Neuritis cranial
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Nervous system disorders
Somnolence
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Nervous system disorders
Speech disorder
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Cardiac disorders
Coronary artery disease
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Cardiac disorders
Pericardial effusion
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Hepatobiliary disorders
Hepatitis
|
0.97%
2/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.97%
2/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
3/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Vascular disorders
Hypovolaemic shock
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.97%
2/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Investigations
Blood bilirubin increased
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Infections and infestations
Arthritis bacterial
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Infections and infestations
Tuberculosis
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.48%
1/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
Other adverse events
| Measure |
Erlotinib
n=207 participants at risk
Erlotinib 150 mg daily
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
53.1%
110/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
35.3%
73/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
27.1%
56/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.6%
53/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.4%
34/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Acne
|
9.7%
20/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
6.3%
13/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
6.8%
14/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
6.3%
13/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
59.9%
124/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Gastrointestinal disorders
Stomatitis
|
20.8%
43/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
12.1%
25/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
23/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
23/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
6.8%
14/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.3%
11/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
General disorders
Mucosal inflammation
|
15.5%
32/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
General disorders
Fatigue
|
14.5%
30/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
General disorders
Chest pain
|
9.2%
19/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
General disorders
Pyrexia
|
7.2%
15/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.1%
56/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.1%
21/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.6%
22/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.2%
19/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.7%
16/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Infections and infestations
Paronychia
|
30.0%
62/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Infections and infestations
Conjunctivitis
|
5.8%
12/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
21.7%
45/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.8%
14/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.5%
28/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.2%
15/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.2%
15/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.8%
12/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Investigations
Alanine aminotransferase increased
|
13.5%
28/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Investigations
Aspartate aminotransferase increased
|
10.6%
22/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Investigations
Blood bilirubin increased
|
5.8%
12/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Nervous system disorders
Headache
|
12.1%
25/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Nervous system disorders
Dizziness
|
9.7%
20/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Eye disorders
Dry eye
|
12.1%
25/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Psychiatric disorders
Insomnia
|
9.2%
19/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Blood and lymphatic system disorders
Anaemia
|
8.2%
17/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
11/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
|
Investigations
Weight decreased
|
5.3%
11/207 • Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER