Trial Outcomes & Findings for MK2206 and Erlotinib Hydrochloride in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Progressed After Previous Response to Erlotinib Hydrochloride Therapy (NCT NCT01294306)

NCT ID: NCT01294306

Last Updated: 2016-11-29

Results Overview

Disease-control rate defined as response rate + stable disease at 12 weeks. Stable disease must have been achieved for 12 weeks or longer. Response evaluated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progression, 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; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 80 participants
• Primary outcome timeframe: At 12 weeks
• Results posted on: 2016-11-29

Participant Flow

Participant milestones

Measure	EGFR-Mutated Tumors Patients with EGFR-mutated tumors.	EGFR Wild-Type Tumors Patients with EGFR wild-type tumors.
Overall Study STARTED	45	35
Overall Study COMPLETED	45	35
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MK2206 and Erlotinib Hydrochloride in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Progressed After Previous Response to Erlotinib Hydrochloride Therapy

Baseline characteristics by cohort

Measure	EGFR-Mutated Tumors n=45 Participants Patients with EGFR-mutated tumors.	EGFR Wild-Type Tumors n=35 Participants Patients with EGFR wild-type tumors.	Total n=80 Participants Total of all reporting groups
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	64 years n=5 Participants	63 years n=7 Participants	64 years n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	20 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	21 Participants n=5 Participants	6 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	27 Participants n=7 Participants	47 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants	35 participants n=7 Participants	80 participants n=5 Participants

PRIMARY outcome

Timeframe: At 12 weeks

Disease-control rate defined as response rate + stable disease at 12 weeks. Stable disease must have been achieved for 12 weeks or longer. Response evaluated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, 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; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.

Outcome measures

Measure	EGFR-Mutated Tumors n=45 Participants Patients with EGFR-mutated tumors.	EGFR Wild-Type Tumors n=35 Participants Patients with EGFR wild-type tumors.
Disease-control Rate	40 percentage of subjects	43 percentage of subjects

PRIMARY outcome

Timeframe: Up to 2 years

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response = CR + PR

Outcome measures

Measure	EGFR-Mutated Tumors n=45 Participants Patients with EGFR-mutated tumors.	EGFR Wild-Type Tumors n=35 Participants Patients with EGFR wild-type tumors.
Objective Response	9 percentage of subjects	3 percentage of subjects

SECONDARY outcome

Timeframe: Up to 2 years

Estimated using the product-limit method of Kaplan and Meier. 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.

Outcome measures

Measure	EGFR-Mutated Tumors n=45 Participants Patients with EGFR-mutated tumors.	EGFR Wild-Type Tumors n=35 Participants Patients with EGFR wild-type tumors.
Median Progression-free Survival	4.4 Months Interval 2.7 to 6.6	4.6 Months Interval 2.9 to 8.5

SECONDARY outcome

Timeframe: Time Frame: Up to 2 years

Toxicities of Grade 3 or higher Attributed to Akt inhibitor MK2206 plus erlotinib hydrochloride, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Outcome measures

Measure	EGFR-Mutated Tumors n=45 Participants Patients with EGFR-mutated tumors.	EGFR Wild-Type Tumors n=35 Participants Patients with EGFR wild-type tumors.
Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride Anemia	0 participants	1 participants
Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride Diarrhea	5 participants	5 participants
Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride Mucositis	4 participants	1 participants
Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride Nausea	1 participants	2 participants
Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride Vomiting	0 participants	1 participants
Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride Fatigue	5 participants	3 participants
Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride Skin infection	0 participants	1 participants
Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride Lung infection	2 participants	0 participants
Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride Urinary tract infection	1 participants	1 participants
Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride Creatinine increased	0 participants	1 participants
Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride Lymphocyte count decreased	6 participants	3 participants
Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride Anorexia	0 participants	1 participants
Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride Dehydration	3 participants	0 participants
Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride Hyperglycemia	3 participants	0 participants
Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride Hypokalemia	2 participants	0 participants
Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride Hyponatremia	0 participants	2 participants
Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride Hypophophatemia	1 participants	0 participants
Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride Myalgia	1 participants	0 participants
Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride Neoplasm	0 participants	1 participants
Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride Dyspnea	1 participants	1 participants
Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride Dry skin	0 participants	3 participants
Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride Erythema multiforme	1 participants	0 participants
Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride Skin peeling (feet)	0 participants	1 participants
Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride Pruritus	0 participants	1 participants
Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride Rash	9 participants	3 participants
Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride Hypertension	1 participants	0 participants

SECONDARY outcome

Timeframe: Up to 2 Years

Estimated using the product-limit method of Kaplan and Meier. Event defined as death due to any cause.

Outcome measures

Measure	EGFR-Mutated Tumors n=45 Participants Patients with EGFR-mutated tumors.	EGFR Wild-Type Tumors n=35 Participants Patients with EGFR wild-type tumors.
Median Overall Survival	10.6 Months Interval 8.6 to 23.2	11.1 Months Interval 7.3 to 22.1

Adverse Events

EGFR-Mutated Tumors

Serious events: 17 serious events

Other events: 45 other events

Deaths: 0 deaths

EGFR Wild-Type Tumors

Serious events: 21 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Measure	EGFR-Mutated Tumors n=45 participants at risk Patients with EGFR-mutated tumors.	EGFR Wild-Type Tumors n=35 participants at risk Patients with EGFR wild-type tumors.
Blood and lymphatic system disorders Anemia	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Cardiac disorders Atrial fibrillation	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Gastrointestinal disorders Abdominal pain	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Gastrointestinal disorders Constipation	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Gastrointestinal disorders Diarrhea	4.4% 2/45 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Gastrointestinal disorders Mucositis oral	15.6% 7/45 • Number of events 9 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	8.6% 3/35 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
General disorders Death NOS	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
General disorders Fatigue	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
General disorders Fever	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
General disorders Infusion site extravasation	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Infections and infestations Lung infection	6.7% 3/45 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	8.6% 3/35 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Infections and infestations Paronychia	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Infections and infestations Sepsis	4.4% 2/45 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Infections and infestations Skin infection	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Infections and infestations Upper respiratory infection	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Infections and infestations Urinary tract infection	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	5.7% 2/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Investigations Creatinine increased	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	5.7% 2/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Investigations Lymphocyte count decreased	11.1% 5/45 • Number of events 8 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	17.1% 6/35 • Number of events 8 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Investigations Neutrophil count decreased	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Metabolism and nutrition disorders Dehydration	6.7% 3/45 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Metabolism and nutrition disorders Hyperglycemia	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Metabolism and nutrition disorders Hypoalbuminemia	4.4% 2/45 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Metabolism and nutrition disorders Hypokalemia	4.4% 2/45 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Metabolism and nutrition disorders Hypophosphatemia	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Progressive Disease, Death NOS	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Progressive disease	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) non-small cell lung cancer	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Nervous system disorders Ataxia	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Nervous system disorders Headache	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	5.7% 2/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Nervous system disorders Transient ischemic attacks	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Psychiatric disorders Confusion	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Reproductive system and breast disorders Vaginal dryness	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Respiratory, thoracic and mediastinal disorders Dyspnea	11.1% 5/45 • Number of events 5 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	5.7% 2/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Respiratory, thoracic and mediastinal disorders Hypoxia	6.7% 3/45 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	5.7% 2/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Ingrown hair (eyelashes)	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Rash acneiform	2.2% 1/45 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Rash maculo-papular	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Skin ulceration	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders skin discoloration (green, gray)	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Vascular disorders Thromboembolic event	4.4% 2/45 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.

Other adverse events

Measure	EGFR-Mutated Tumors n=45 participants at risk Patients with EGFR-mutated tumors.	EGFR Wild-Type Tumors n=35 participants at risk Patients with EGFR wild-type tumors.
Skin and subcutaneous tissue disorders finger cracks	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders finger tip cracks	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 6 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders ingrown toenail	2.2% 1/45 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders scaling on toes	2.2% 1/45 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders skin cracks	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders subcutaneous lesion in elbow	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Vascular disorders Hot flashes	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Vascular disorders Hypertension	37.8% 17/45 • Number of events 85 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	34.3% 12/35 • Number of events 45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Vascular disorders Hypotension	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Vascular disorders Thromboembolic event	4.4% 2/45 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Blood and lymphatic system disorders Anemia	37.8% 17/45 • Number of events 46 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	54.3% 19/35 • Number of events 79 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Blood and lymphatic system disorders Aortic Aneurysm	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 8 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Blood and lymphatic system disorders Aortic aneurysm	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Blood and lymphatic system disorders Ascending aortic aneurysm	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Cardiac disorders Aortic valve disease	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Cardiac disorders Heart failure	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Cardiac disorders Palpitations	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Cardiac disorders Pericardial effusion	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Cardiac disorders Sinus tachycardia	8.9% 4/45 • Number of events 4 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	5.7% 2/35 • Number of events 4 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Ear and labyrinth disorders Ear pain	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	5.7% 2/35 • Number of events 5 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Ear and labyrinth disorders Hearing impaired	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Ear and labyrinth disorders Tinnitus	2.2% 1/45 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Ear and labyrinth disorders Vertigo	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Ear and labyrinth disorders fluid in ear	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Eye disorders Blepharitis	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Eye disorders Blurred vision	2.2% 1/45 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Eye disorders Blurry Vision	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Eye disorders Cataract	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Eye disorders Conjunctivitis	6.7% 3/45 • Number of events 5 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Eye disorders Dry eye	17.8% 8/45 • Number of events 33 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	8.6% 3/35 • Number of events 8 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Eye disorders Eye pain	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Eye disorders Ingrown eyelashes	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Eye disorders Redness Irritation	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Eye disorders Sensitivity to sun	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Eye disorders Watery Eyes	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Eye disorders eye irritation	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Gastrointestinal disorders Abdominal pain	15.6% 7/45 • Number of events 11 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	17.1% 6/35 • Number of events 17 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Gastrointestinal disorders Bloating	2.2% 1/45 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Gastrointestinal disorders Constipation	22.2% 10/45 • Number of events 21 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	28.6% 10/35 • Number of events 35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Gastrointestinal disorders Diarrhea	80.0% 36/45 • Number of events 123 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	77.1% 27/35 • Number of events 114 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Gastrointestinal disorders Dry mouth	20.0% 9/45 • Number of events 21 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	14.3% 5/35 • Number of events 7 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Gastrointestinal disorders Dyspepsia	6.7% 3/45 • Number of events 5 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Gastrointestinal disorders Dysphagia	6.7% 3/45 • Number of events 5 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Gastrointestinal disorders Flatulence	4.4% 2/45 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	5.7% 2/35 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Gastrointestinal disorders Gastritis	4.4% 2/45 • Number of events 11 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Gastrointestinal disorders Gastroesophageal reflux disease	4.4% 2/45 • Number of events 8 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	8.6% 3/35 • Number of events 5 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Gastrointestinal disorders Hemorrhoidal hemorrhage	2.2% 1/45 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Gastrointestinal disorders Hemorrhoids	4.4% 2/45 • Number of events 5 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Gastrointestinal disorders Intermittent stomach aches	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Gastrointestinal disorders Mucositis oral	48.9% 22/45 • Number of events 44 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	28.6% 10/35 • Number of events 21 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Gastrointestinal disorders Nausea	26.7% 12/45 • Number of events 25 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	40.0% 14/35 • Number of events 26 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Gastrointestinal disorders Oral hemorrhage	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Gastrointestinal disorders Oral pain	4.4% 2/45 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	5.7% 2/35 • Number of events 5 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Gastrointestinal disorders Rectal hemorrhage	2.2% 1/45 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	5.7% 2/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Gastrointestinal disorders Stomach Flu	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Gastrointestinal disorders Stomach pain	2.2% 1/45 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	5.7% 2/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Gastrointestinal disorders Vomiting	22.2% 10/45 • Number of events 14 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	22.9% 8/35 • Number of events 10 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Gastrointestinal disorders rough in mouth/sips	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
General disorders Chills	8.9% 4/45 • Number of events 5 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	17.1% 6/35 • Number of events 6 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
General disorders Death NOS	24.4% 11/45 • Number of events 11 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	28.6% 10/35 • Number of events 10 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
General disorders Edema face	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
General disorders Edema limbs	15.6% 7/45 • Number of events 11 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	17.1% 6/35 • Number of events 12 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
General disorders Fatigue	77.8% 35/45 • Number of events 115 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	85.7% 30/35 • Number of events 101 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
General disorders Fever	11.1% 5/45 • Number of events 7 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	5.7% 2/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
General disorders Gait disturbance	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	5.7% 2/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
General disorders Malaise	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
General disorders Neck edema	2.2% 1/45 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
General disorders Non-cardiac chest pain	6.7% 3/45 • Number of events 10 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	11.4% 4/35 • Number of events 16 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
General disorders Pain	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Immune system disorders Allergic reaction	2.2% 1/45 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Infections and infestations Bronchial infection	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Infections and infestations Infected abrasion	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Infections and infestations Infected abrasion wound	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Infections and infestations Lung infection	4.4% 2/45 • Number of events 4 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Infections and infestations Nail infection	2.2% 1/45 • Number of events 5 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 14 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Infections and infestations Otitis externa	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Infections and infestations Otitis media	2.2% 1/45 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Infections and infestations Paronychia	20.0% 9/45 • Number of events 20 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	14.3% 5/35 • Number of events 25 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Infections and infestations Pharyngitis	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Infections and infestations Rash pustular	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Infections and infestations Sinus	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Infections and infestations Sinusitis	2.2% 1/45 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	5.7% 2/35 • Number of events 7 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Infections and infestations Skin infection	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	5.7% 2/35 • Number of events 5 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Infections and infestations Upper respiratory infection	4.4% 2/45 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	11.4% 4/35 • Number of events 8 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Infections and infestations Urinary tract infection	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	11.4% 4/35 • Number of events 5 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Infections and infestations Vaginal infection	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Infections and infestations Vulval infection	2.2% 1/45 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Infections and infestations Yeast Infection	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Infections and infestations oral thrush	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Injury, poisoning and procedural complications Burn	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Injury, poisoning and procedural complications Fall	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	5.7% 2/35 • Number of events 5 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Investigations Activated partial thromboplastin time pr	4.4% 2/45 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 13 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Investigations Alanine aminotransferase increased	15.6% 7/45 • Number of events 10 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	14.3% 5/35 • Number of events 17 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Investigations Alkaline phosphatase increased	31.1% 14/45 • Number of events 34 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	20.0% 7/35 • Number of events 20 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Investigations Aspartate aminotransferase increased	24.4% 11/45 • Number of events 21 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	25.7% 9/35 • Number of events 43 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Investigations Blood bilirubin increased	28.9% 13/45 • Number of events 39 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	17.1% 6/35 • Number of events 23 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Investigations Cholesterol high	2.2% 1/45 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 6 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Investigations Creatinine increased	15.6% 7/45 • Number of events 34 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	34.3% 12/35 • Number of events 75 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Investigations INR increased	4.4% 2/45 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	5.7% 2/35 • Number of events 39 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Investigations Lymphocyte count decreased	31.1% 14/45 • Number of events 46 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	42.9% 15/35 • Number of events 56 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Investigations Neutrophil count decreased	6.7% 3/45 • Number of events 7 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Investigations Platelet count decreased	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Investigations Right bundle branch block	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Investigations Weight loss	24.4% 11/45 • Number of events 35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	37.1% 13/35 • Number of events 71 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Investigations White blood cell decreased	15.6% 7/45 • Number of events 35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	11.4% 4/35 • Number of events 8 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Metabolism and nutrition disorders Anorexia	51.1% 23/45 • Number of events 47 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	60.0% 21/35 • Number of events 53 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Metabolism and nutrition disorders Dehydration	6.7% 3/45 • Number of events 5 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	11.4% 4/35 • Number of events 4 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Metabolism and nutrition disorders Glucose intolerance	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 6 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	8.6% 3/35 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Metabolism and nutrition disorders Hyperglycemia	31.1% 14/45 • Number of events 54 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	34.3% 12/35 • Number of events 26 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	8.6% 3/35 • Number of events 9 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Metabolism and nutrition disorders Hypernatremia	8.9% 4/45 • Number of events 9 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	8.6% 3/35 • Number of events 6 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Metabolism and nutrition disorders Hypertriglyceridemia	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Metabolism and nutrition disorders Hypoalbuminemia	35.6% 16/45 • Number of events 28 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	28.6% 10/35 • Number of events 66 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Metabolism and nutrition disorders Hypocalcemia	17.8% 8/45 • Number of events 24 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	22.9% 8/35 • Number of events 14 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Metabolism and nutrition disorders Hypoglycemia	11.1% 5/45 • Number of events 22 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	14.3% 5/35 • Number of events 10 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Metabolism and nutrition disorders Hypokalemia	17.8% 8/45 • Number of events 16 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	14.3% 5/35 • Number of events 7 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Metabolism and nutrition disorders Hypomagnesemia	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	8.6% 3/35 • Number of events 8 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Metabolism and nutrition disorders Hyponatremia	26.7% 12/45 • Number of events 21 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	31.4% 11/35 • Number of events 13 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Metabolism and nutrition disorders Hypophosphatemia	20.0% 9/45 • Number of events 15 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	14.3% 5/35 • Number of events 10 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Metabolism and nutrition disorders LDH Increased	2.2% 1/45 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Metabolism and nutrition disorders Obesity	11.1% 5/45 • Number of events 25 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	14.3% 5/35 • Number of events 12 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Musculoskeletal and connective tissue disorders Arthralgia	11.1% 5/45 • Number of events 10 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	5.7% 2/35 • Number of events 4 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Musculoskeletal and connective tissue disorders Arthritis	2.2% 1/45 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Musculoskeletal and connective tissue disorders Back pain	13.3% 6/45 • Number of events 25 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	22.9% 8/35 • Number of events 16 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Musculoskeletal and connective tissue disorders Back spasms	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Musculoskeletal and connective tissue disorders Bone pain	13.3% 6/45 • Number of events 18 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	14.3% 5/35 • Number of events 9 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Musculoskeletal and connective tissue disorders Chest wall pain	8.9% 4/45 • Number of events 12 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Musculoskeletal and connective tissue disorders Flank pain	2.2% 1/45 • Number of events 4 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 10 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	11.1% 5/45 • Number of events 6 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	11.4% 4/35 • Number of events 8 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Musculoskeletal and connective tissue disorders Joint Pain	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	2.2% 1/45 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	5.7% 2/35 • Number of events 4 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	2.2% 1/45 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Musculoskeletal and connective tissue disorders Myalgia	13.3% 6/45 • Number of events 19 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	11.4% 4/35 • Number of events 11 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Musculoskeletal and connective tissue disorders Neck pain	6.7% 3/45 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Musculoskeletal and connective tissue disorders Pain in extremity	11.1% 5/45 • Number of events 7 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	11.4% 4/35 • Number of events 9 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Musculoskeletal and connective tissue disorders hand cramps	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Musculoskeletal and connective tissue disorders leg cramps	2.2% 1/45 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Musculoskeletal and connective tissue disorders muscle cramps	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Disease Progression	48.9% 22/45 • Number of events 22 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	57.1% 20/35 • Number of events 20 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Nervous system disorders Ataxia	6.7% 3/45 • Number of events 11 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 11 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Nervous system disorders Dizziness	13.3% 6/45 • Number of events 10 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	11.4% 4/35 • Number of events 6 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Nervous system disorders Dysarthria	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Nervous system disorders Dysgeusia	35.6% 16/45 • Number of events 48 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	31.4% 11/35 • Number of events 27 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Nervous system disorders Dysphasia	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Nervous system disorders Headache	13.3% 6/45 • Number of events 14 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	11.4% 4/35 • Number of events 8 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Nervous system disorders Hydrocephalus	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Nervous system disorders Lethargy	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Nervous system disorders Memory impairment	2.2% 1/45 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	11.4% 4/35 • Number of events 13 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Nervous system disorders Paresthesia	4.4% 2/45 • Number of events 9 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	11.4% 4/35 • Number of events 8 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Nervous system disorders Peripheral sensory neuropathy	11.1% 5/45 • Number of events 14 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	11.4% 4/35 • Number of events 25 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Nervous system disorders sciatic like pain	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Psychiatric disorders Agitation	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Psychiatric disorders Anxiety	6.7% 3/45 • Number of events 12 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	5.7% 2/35 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Psychiatric disorders Confusion	8.9% 4/45 • Number of events 5 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Psychiatric disorders Crying spells	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Psychiatric disorders Delirium	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Psychiatric disorders Depression	4.4% 2/45 • Number of events 11 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	8.6% 3/35 • Number of events 5 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Psychiatric disorders Hallucinations	2.2% 1/45 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Psychiatric disorders Insomnia	6.7% 3/45 • Number of events 20 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	8.6% 3/35 • Number of events 11 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Renal and urinary disorders Acute kidney injury	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Renal and urinary disorders Acute tubular necrosis	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Renal and urinary disorders Chronic kidney disease	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 17 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Renal and urinary disorders Hematuria	4.4% 2/45 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Renal and urinary disorders Proteinuria	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 6 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Renal and urinary disorders Urinary incontinence	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	5.7% 2/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Renal and urinary disorders Urinary tract pain	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Reproductive system and breast disorders Vaginal dryness	2.2% 1/45 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	8.9% 4/45 • Number of events 20 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	14.3% 5/35 • Number of events 10 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Respiratory, thoracic and mediastinal disorders Blood Streaked Sputum	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Respiratory, thoracic and mediastinal disorders Chest congestion, possible infection	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Respiratory, thoracic and mediastinal disorders Cough	44.4% 20/45 • Number of events 66 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	40.0% 14/35 • Number of events 67 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Respiratory, thoracic and mediastinal disorders Diminished Breath Sounds	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Respiratory, thoracic and mediastinal disorders Dry Throat	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Respiratory, thoracic and mediastinal disorders Dyspnea	37.8% 17/45 • Number of events 34 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	42.9% 15/35 • Number of events 35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Respiratory, thoracic and mediastinal disorders Epistaxis	6.7% 3/45 • Number of events 6 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	11.4% 4/35 • Number of events 10 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Respiratory, thoracic and mediastinal disorders Hoarseness	4.4% 2/45 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	5.7% 2/35 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.4% 2/45 • Number of events 6 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 4 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Respiratory, thoracic and mediastinal disorders Postnasal drip	4.4% 2/45 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Respiratory, thoracic and mediastinal disorders Productive cough	6.7% 3/45 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	17.1% 6/35 • Number of events 8 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Respiratory, thoracic and mediastinal disorders Respiratory illness	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Respiratory, thoracic and mediastinal disorders Rhinitis	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Respiratory, thoracic and mediastinal disorders Runny nose	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Respiratory, thoracic and mediastinal disorders Sore throat	6.7% 3/45 • Number of events 9 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	11.4% 4/35 • Number of events 5 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Respiratory, thoracic and mediastinal disorders Wheezing	4.4% 2/45 • Number of events 5 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	8.6% 3/35 • Number of events 10 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Respiratory, thoracic and mediastinal disorders chest congestion	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Respiratory, thoracic and mediastinal disorders chest tightness	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Alopecia	6.7% 3/45 • Number of events 11 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	14.3% 5/35 • Number of events 26 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Bullous dermatitis	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Cracked skin on feet	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Decadron rash	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Desquamation	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Desquamation of lips	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Desquamation right palm/fingers	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Dry desquamation	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Dry skin	57.8% 26/45 • Number of events 119 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	68.6% 24/35 • Number of events 115 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Erythema multiforme	11.1% 5/45 • Number of events 17 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	8.6% 3/35 • Number of events 4 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Erythematous scaly rash	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Finger Cracks	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Finger tip cracks	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Hand Food Syndrome	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Hand-Foot Skin Reaction	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Hirsutism	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 9 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Hypertrichosis	4.4% 2/45 • Number of events 5 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders In grown toenail	2.2% 1/45 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Ingrown toe nail	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Ingrown toe nail - right foot	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Ingrown toenail	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Mottle rash	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Nail loss	2.2% 1/45 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	5.7% 2/35 • Number of events 5 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Nail ridging	2.2% 1/45 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	5.7% 2/35 • Number of events 30 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndro	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	5.7% 2/35 • Number of events 4 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Peeling @ bottoms of feet	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Peeling @bottoms of feet	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Pruritus	35.6% 16/45 • Number of events 59 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	42.9% 15/35 • Number of events 39 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Rash acneiform	48.9% 22/45 • Number of events 80 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	37.1% 13/35 • Number of events 54 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Rash maculo-papular	51.1% 23/45 • Number of events 92 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	48.6% 17/35 • Number of events 86 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Scaling on toes	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Scalp pain	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	4.4% 2/45 • Number of events 8 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	5.7% 2/35 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Skin hypopigmentation	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Skin ulceration	4.4% 2/45 • Number of events 5 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders Urticaria	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders cracks on feet	2.2% 1/45 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	0.00% 0/35 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders decadron rash	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 3 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders desquamation of palm/fingers	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders desquamation of r palm/fingers	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders desquamation, right palm/fingers	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.
Skin and subcutaneous tissue disorders dry desquamation	0.00% 0/45 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 4 years and 8 months. Includes all adverse events regardless of attribution and grade.

Additional Information

DCC Project Administrator

California Cancer Consortium

Phone: 626-256-4673

Email: CCCP@coh.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60