Trial Outcomes & Findings for A Study on the Correlation Between Tarceva (Erlotinib) - Induced Rash and Efficacy in EGFR Mutated Participants With Advanced Non-Small Cell Lung Cancer Receiving First-Line Therapy (NCT NCT01174563)

Last Updated: 2018-09-17

Results Overview

PFS was defined as the time from start of treatment to the date of the first documented progression according to revised Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 or the date of death for any reason in the absence of progressive disease (PD). Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

Day 1 of treatment period until disease progression or death (approximately up to 67 months)

Results posted on

2018-09-17

Participant Flow

A total of 60 participants were enrolled in the study from 12 centers across Israel.

Participant milestones

Participant milestones
Measure	Erlotinib Participants received 150 milligrams (mg) of Erlotinib orally daily, from Day 1 of the treatment period until unacceptable toxicity, disease progression or withdrawal due to any reason.
Overall Study STARTED	60
Overall Study Efficacy Set	59
Overall Study Safety Set	59
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	60

Reasons for withdrawal

Reasons for withdrawal
Measure	Erlotinib Participants received 150 milligrams (mg) of Erlotinib orally daily, from Day 1 of the treatment period until unacceptable toxicity, disease progression or withdrawal due to any reason.
Overall Study Progressive Disease	45
Overall Study Death	5
Overall Study Investigator's Discretion	5
Overall Study Participant Withdrew Consent	3
Overall Study Rash Adverse Event	1
Overall Study Sponsor's decision	1

Baseline Characteristics

A Study on the Correlation Between Tarceva (Erlotinib) - Induced Rash and Efficacy in EGFR Mutated Participants With Advanced Non-Small Cell Lung Cancer Receiving First-Line Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erlotinib n=60 Participants Participants received 150 milligrams (mg) of Erlotinib orally daily, from Day 1 of the treatment period until unacceptable toxicity, disease progression or withdrawal due to any reason.
Age, Continuous	69.0 years STANDARD_DEVIATION 12.3 • n=99 Participants
Sex: Female, Male Female	41 Participants n=99 Participants
Sex: Female, Male Male	19 Participants n=99 Participants

PRIMARY outcome

Timeframe: Day 1 of treatment period until disease progression or death (approximately up to 67 months)

Population: Efficacy set included all participants who received at least one dose of study drug. Here, "Number Analyzed" represents the number of participants who were evaluable at specified time points.

Outcome measures

Outcome measures
Measure	Erlotinib n=59 Participants Participants received 150 milligrams (mg) of Erlotinib orally daily, from Day 1 of the treatment period until unacceptable toxicity, disease progression or withdrawal due to any reason.
Progression-free Survival (PFS) According to Grade of Rash Grade 0	2.16 months Interval 1.51 to Upper limit of 95% CI for Grade 0 was not estimated due to low number of participants with the events.
Progression-free Survival (PFS) According to Grade of Rash Grade 1	6.62 months Interval 3.57 to 13.48
Progression-free Survival (PFS) According to Grade of Rash Grade 2	10.00 months Interval 7.31 to 23.61
Progression-free Survival (PFS) According to Grade of Rash Grade 3	15.28 months Interval 10.62 to 25.77

SECONDARY outcome

Timeframe: Day 1 of treatment period until disease progression or death (approximately up to 67 months)

Outcome measures

Outcome measures
Measure	Erlotinib n=59 Participants Participants received 150 milligrams (mg) of Erlotinib orally daily, from Day 1 of the treatment period until unacceptable toxicity, disease progression or withdrawal due to any reason.
Percentage of Participants With Erlotinib Dose Reductions Due to Rash Grade 3-4 Rash Grade III	8.5 percentage of participants

SECONDARY outcome

Timeframe: Day 1 of treatment period until disease progression or death (approximately up to 67 months)

Outcome measures

Outcome measures
Measure	Erlotinib n=59 Participants Participants received 150 milligrams (mg) of Erlotinib orally daily, from Day 1 of the treatment period until unacceptable toxicity, disease progression or withdrawal due to any reason.
Progression-Free Survival (PFS) in Participants With Erlotinib Dose Reductions Due to Rash Grade 3-4 Rash grade III	13.72 months Interval 7.31 to 50.13

Adverse Events

Erlotinib

Serious events: 19 serious events

Other events: 59 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Erlotinib n=59 participants at risk Participants received 150 milligrams (mg) of Erlotinib orally daily, from Day 1 of the treatment period until unacceptable toxicity, disease progression or withdrawal due to any reason.
Cardiac disorders Bradycardia	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Eye disorders Vision blurred	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders Diarrhea	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders Duodenal ulcer	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders Gastritis	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders Gastroduodenitis	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders Hematemesis	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders Chest pain	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders General physical health deterioration	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders Pyrexia	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations Ophthalmic herpes zoster	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations Pneumonia	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations Sepsis	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations Upper respiratory tract infection	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Injury, poisoning and procedural complications Fall	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Injury, poisoning and procedural complications Femoral neck fracture	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Injury, poisoning and procedural complications Fractured sacrum	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Injury, poisoning and procedural complications Hip fracture	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Injury, poisoning and procedural complications Upper limb fracture	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders Hypocalcaemia	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders Hypokalemia	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders Back pain	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders Cerebral artery occlusion	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders Cerebrovascular accident	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders Dizziness	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Psychiatric disorders Depression	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Renal and urinary disorders Acute kidney injury	3.4% 2/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders Bronchitis	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	1.7% 1/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Other adverse events

Other adverse events
Measure	Erlotinib n=59 participants at risk Participants received 150 milligrams (mg) of Erlotinib orally daily, from Day 1 of the treatment period until unacceptable toxicity, disease progression or withdrawal due to any reason.
Eye disorders Blepharitis	6.8% 4/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Eye disorders Conjunctivitis	8.5% 5/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Eye disorders Dry eye	10.2% 6/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Eye disorders Growth of eyelashes	8.5% 5/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Eye disorders Vision blurred	5.1% 3/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders Abdominal pain	18.6% 11/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders Constipation	13.6% 8/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders Diarrhea	59.3% 35/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders Gingivitis	6.8% 4/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders Nausea	11.9% 7/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders Stomatitis	5.1% 3/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders Vomiting	8.5% 5/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders Asthenia	13.6% 8/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders Fatigue	32.2% 19/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders Influenza like illness	15.3% 9/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders Pain	8.5% 5/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders Pyrexia	11.9% 7/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations Eye infection	5.1% 3/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations Nasopharyngitis	6.8% 4/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations Paronychia	11.9% 7/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations Tooth infection	6.8% 4/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations Upper respiratory tract infection	6.8% 4/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations Urinary tract infection	10.2% 6/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations Blood bilirubin increased	5.1% 3/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations Carcinoembryonic antigen increased	5.1% 3/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations Weight decreased	6.8% 4/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders Decreased appetite	10.2% 6/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders Back pain	15.3% 9/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	5.1% 3/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	6.8% 4/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders Pain in extremity	5.1% 3/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders Dizziness	15.3% 9/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders Dysgeusia	6.8% 4/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders Headache	8.5% 5/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Reproductive system and breast disorders Pelvic pain	6.8% 4/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders Cough	20.3% 12/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders Dysphonia	5.1% 3/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders Dyspnoea	11.9% 7/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders Alopecia	25.4% 15/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders Dry skin	27.1% 16/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders Hirsutism	5.1% 3/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders Pruritus	10.2% 6/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders Rash	93.2% 55/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders Dyspepsia	8.5% 5/59 • From signing of informed consent form up to end of study (approximately up to 67 months) An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

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