Trial Outcomes & Findings for A Study of EGF816 and Gefitinib in TKI-naïve EGFR-mutant Non-Small Cell Lung Cancer (NCT NCT03292133)

Last Updated: 2025-06-10

Results Overview

The percentage of participants that are free from objective disease progression or death at 9 months after the start treatment. Progression is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

9 months

Results posted on

2025-06-10

Participant Flow

Participant milestones

Participant milestones
Measure	EGF816 + Gefitinib * All patients will receive gefitinib orally once daily * EGF816 will be administered orally once daily * Participant will be requested to maintain a medication diary of each dose of medication EGF816: EGF816 is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplying Gefitinib: Gefitinib is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplying
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of EGF816 and Gefitinib in TKI-naïve EGFR-mutant Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EGF816 + Gefitinib n=11 Participants * All patients will receive gefitinib orally once daily * EGF816 will be administered orally once daily * Participant will be requested to maintain a medication diary of each dose of medication EGF816: EGF816 is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplying Gefitinib: Gefitinib is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplying
Age, Continuous	58 years n=99 Participants
Sex: Female, Male Female	5 Participants n=99 Participants
Sex: Female, Male Male	6 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	3 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants
Race (NIH/OMB) White	7 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: 9 months

Outcome measures

Outcome measures
Measure	EGF816 + Gefitinib n=11 Participants * All patients will receive gefitinib orally once daily * EGF816 will be administered orally once daily * Participant will be requested to maintain a medication diary of each dose of medication EGF816: EGF816 is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplying Gefitinib: Gefitinib is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplying
9 Months Progression Free Rate	7 Participants

SECONDARY outcome

Timeframe: 4 years and 4 months

The number of participants that achieve either a complete response (CR) or a partial response (PR). Response is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. * Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. All CRs and PRs must be confirmed by a second assessment not earlier than 4 weeks after the criteria for response are first met.

Outcome measures

Outcome measures
Measure	EGF816 + Gefitinib n=11 Participants * All patients will receive gefitinib orally once daily * EGF816 will be administered orally once daily * Participant will be requested to maintain a medication diary of each dose of medication EGF816: EGF816 is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplying Gefitinib: Gefitinib is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplying
Overall Response Rate (ORR)	8 Participants

SECONDARY outcome

Timeframe: 6 years

Overall survival is defined as time from the start of treatment until death or loss to follow up. Overall survival will be analyzed using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	EGF816 + Gefitinib n=11 Participants * All patients will receive gefitinib orally once daily * EGF816 will be administered orally once daily * Participant will be requested to maintain a medication diary of each dose of medication EGF816: EGF816 is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplying Gefitinib: Gefitinib is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplying
Median Overall Survival	35.7 months Interval 6.18 to Upper confidence interval not reached because too few survival events occurred.

SECONDARY outcome

Timeframe: 4.2 years

PFS is defined as the time from start of treatment to the time of objective disease progression, death, or loss to follow up. Progression is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).

Outcome measures

Outcome measures
Measure	EGF816 + Gefitinib n=11 Participants * All patients will receive gefitinib orally once daily * EGF816 will be administered orally once daily * Participant will be requested to maintain a medication diary of each dose of medication EGF816: EGF816 is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplying Gefitinib: Gefitinib is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplying
Median Progression Free Survival (PFS)	20.86 months Interval 5.42 to 39.57

SECONDARY outcome

Timeframe: Start of treatment through 30 days after the end of treatment (max 4 years and 5 months)

Treatment-related adverse events, defined as those at least possibly related to study treatment, are summarized below as a measure of patient safety and treatment tolerability. Subjects were evaluated for adverse events by the Common Terminology Criteria for Adverse Events (CTCAE) v4. For each treatment-related event, subjects are counted below by the highest grade they experienced on study per CTCAE v 4.0 to demonstrate the range and severity of treatment-related toxicities documented on study. Grade refers to the severity of the toxicity, with Grade 1 corresponding to mild toxicity, Grade 2 to moderate toxicity, and Grade 3 to severe toxicity. Patients who did not experience a given event at any grade are counted in the final category for each row.

Outcome measures

Outcome measures
Measure	EGF816 + Gefitinib n=11 Participants * All patients will receive gefitinib orally once daily * EGF816 will be administered orally once daily * Participant will be requested to maintain a medication diary of each dose of medication EGF816: EGF816 is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplying Gefitinib: Gefitinib is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplying
Summary of Treatment-related Adverse Events Eye Pain · Grade 2 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Rash maculo-papular · Grade 2 (CTCAE v4)	2 Participants
Summary of Treatment-related Adverse Events Diarrhea · Grade 3 (CTCAE v4)	2 Participants
Summary of Treatment-related Adverse Events Weight gain · Grade 2 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Weight gain · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Anorexia · Grade 2 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Anorexia · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Anorexia · Subject did not experience this treatment-related toxicity	10 Participants
Summary of Treatment-related Adverse Events Hypomagnesemia · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Hypomagnesemia · Subject did not experience this treatment-related toxicity	10 Participants
Summary of Treatment-related Adverse Events Hyponatremia · Grade 1 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Hyponatremia · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Hyponatremia · Subject did not experience this treatment-related toxicity	10 Participants
Summary of Treatment-related Adverse Events Metabolism and nutrition disorders - other, specify · Grade 1 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Metabolism and nutrition disorders - other, specify · Grade 2 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Metabolism and nutrition disorders - other, specify · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Metabolism and nutrition disorders - other, specify · Subject did not experience this treatment-related toxicity	10 Participants
Summary of Treatment-related Adverse Events Arthralgia · Grade 1 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Arthralgia · Grade 2 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Arthralgia · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Myalgia · Grade 1 (CTCAE v4)	3 Participants
Summary of Treatment-related Adverse Events Myalgia · Grade 2 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Myalgia · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Myalgia · Subject did not experience this treatment-related toxicity	8 Participants
Summary of Treatment-related Adverse Events Renal and urinary disorders - other, specify · Grade 1 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Renal and urinary disorders - other, specify · Grade 2 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Renal and urinary disorders - other, specify · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Renal and urinary disorders - other, specify · Subject did not experience this treatment-related toxicity	10 Participants
Summary of Treatment-related Adverse Events Erectile dysfunction · Grade 1 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Erectile dysfunction · Grade 2 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Erectile dysfunction · Subject did not experience this treatment-related toxicity	10 Participants
Summary of Treatment-related Adverse Events Vaginal pain · Grade 1 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Vaginal pain · Grade 2 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Vaginal pain · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Vaginal pain · Subject did not experience this treatment-related toxicity	10 Participants
Summary of Treatment-related Adverse Events Cough · Grade 1 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Cough · Grade 2 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Cough · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Dyspnea · Grade 1 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Dyspnea · Grade 2 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Dyspnea · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Dyspnea · Subject did not experience this treatment-related toxicity	10 Participants
Summary of Treatment-related Adverse Events Epistaxis · Grade 1 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Epistaxis · Grade 2 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Epistaxis · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Rash maculo-papular · Grade 3 (CTCAE v4)	3 Participants
Summary of Treatment-related Adverse Events Epistaxis · Subject did not experience this treatment-related toxicity	10 Participants
Summary of Treatment-related Adverse Events Pneumonitis · Grade 1 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Pneumonitis · Grade 2 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Pneumonitis · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Pneumonitis · Subject did not experience this treatment-related toxicity	10 Participants
Summary of Treatment-related Adverse Events Sore throat · Grade 1 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Sore throat · Grade 2 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Sore throat · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Sore throat · Subject did not experience this treatment-related toxicity	10 Participants
Summary of Treatment-related Adverse Events Alopecia · Grade 1 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Alopecia · Grade 2 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Alopecia · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Alopecia · Subject did not experience this treatment-related toxicity	9 Participants
Summary of Treatment-related Adverse Events Bullous dermatitis · Grade 1 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Bullous dermatitis · Grade 2 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Bullous dermatitis · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Bullous dermatitis · Subject did not experience this treatment-related toxicity	10 Participants
Summary of Treatment-related Adverse Events Dry skin · Grade 1 (CTCAE v4)	4 Participants
Summary of Treatment-related Adverse Events Dry skin · Grade 2 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Dry skin · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Dry skin · Subject did not experience this treatment-related toxicity	6 Participants
Summary of Treatment-related Adverse Events Erythema multiforme · Grade 1 (CTCAE v4)	2 Participants
Summary of Treatment-related Adverse Events Erythema multiforme · Grade 2 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Erythema multiforme · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Erythema multiforme · Subject did not experience this treatment-related toxicity	9 Participants
Summary of Treatment-related Adverse Events Pain of skin · Grade 2 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Pain of skin · Subject did not experience this treatment-related toxicity	9 Participants
Summary of Treatment-related Adverse Events Pruritis · Grade 1 (CTCAE v4)	4 Participants
Summary of Treatment-related Adverse Events Pruritis · Grade 2 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Pruritis · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Pruritis · Subject did not experience this treatment-related toxicity	6 Participants
Summary of Treatment-related Adverse Events Rash acneiform · Grade 2 (CTCAE v4)	2 Participants
Summary of Treatment-related Adverse Events Rash acneiform · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Rash maculo-papular · Grade 1 (CTCAE v4)	3 Participants
Summary of Treatment-related Adverse Events Scalp pain · Grade 1 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Scalp pain · Grade 2 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Scalp pain · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Skin/subcutaneous tissue disorders - other, specify · Grade 1 (CTCAE v4)	3 Participants
Summary of Treatment-related Adverse Events Skin/subcutaneous tissue disorders - other, specify · Grade 2 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Skin/subcutaneous tissue disorders - other, specify · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Skin/subcutaneous tissue disorders - other, specify · Subject did not experience this treatment-related toxicity	7 Participants
Summary of Treatment-related Adverse Events Anemia · Grade 1 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Anemia · Grade 2 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Anemia · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Anemia · Subject did not experience this treatment-related toxicity	10 Participants
Summary of Treatment-related Adverse Events Cardiac disorders - other, specify · Grade 1 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Cardiac disorders - other, specify · Grade 2 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Cardiac disorders - other, specify · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Cardiac disorders - other, specify · Subject did not experience this treatment-related toxicity	10 Participants
Summary of Treatment-related Adverse Events Dry eye · Grade 1 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Dry eye · Grade 2 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Dry eye · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Dry eye · Subject did not experience this treatment-related toxicity	10 Participants
Summary of Treatment-related Adverse Events Eye Pain · Grade 1 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Eye Pain · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Eye Pain · Subject did not experience this treatment-related toxicity	10 Participants
Summary of Treatment-related Adverse Events Abdominal Pain · Grade 1 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Abdominal Pain · Grade 2 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Abdominal Pain · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Abdominal Pain · Subject did not experience this treatment-related toxicity	10 Participants
Summary of Treatment-related Adverse Events Bloating · Grade 1 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Bloating · Grade 2 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Bloating · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Bloating · Subject did not experience this treatment-related toxicity	10 Participants
Summary of Treatment-related Adverse Events Diarrhea · Grade 1 (CTCAE v4)	6 Participants
Summary of Treatment-related Adverse Events Diarrhea · Grade 2 (CTCAE v4)	3 Participants
Summary of Treatment-related Adverse Events Diarrhea · Subject did not experience this treatment-related toxicity	0 Participants
Summary of Treatment-related Adverse Events Dry mouth · Grade 1 (CTCAE v4)	3 Participants
Summary of Treatment-related Adverse Events Dry mouth · Grade 2 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Dry mouth · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Dry mouth · Subject did not experience this treatment-related toxicity	8 Participants
Summary of Treatment-related Adverse Events Dyspepsia · Grade 1 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Dyspepsia · Grade 2 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Dyspepsia · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Dyspepsia · Subject did not experience this treatment-related toxicity	10 Participants
Summary of Treatment-related Adverse Events Gastroesophageal Reflux disease · Grade 1 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Gastroesophageal Reflux disease · Grade 2 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Gastroesophageal Reflux disease · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Gastroesophageal Reflux disease · Subject did not experience this treatment-related toxicity	10 Participants
Summary of Treatment-related Adverse Events Gastrointestinal disorders - other, specify · Grade 1 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Gastrointestinal disorders - other, specify · Grade 2 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Gastrointestinal disorders - other, specify · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Gastrointestinal disorders - other, specify · Subject did not experience this treatment-related toxicity	9 Participants
Summary of Treatment-related Adverse Events Mucositis oral · Grade 1 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Mucositis oral · Grade 2 (CTCAE v4)	2 Participants
Summary of Treatment-related Adverse Events Mucositis oral · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Mucositis oral · Subject did not experience this treatment-related toxicity	8 Participants
Summary of Treatment-related Adverse Events Nausea · Grade 1 (CTCAE v4)	2 Participants
Summary of Treatment-related Adverse Events Nausea · Grade 2 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Nausea · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Nausea · Subject did not experience this treatment-related toxicity	9 Participants
Summary of Treatment-related Adverse Events Oral pain · Grade 1 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Oral pain · Grade 2 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Oral pain · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Oral pain · Subject did not experience this treatment-related toxicity	10 Participants
Summary of Treatment-related Adverse Events Fatigue · Grade 1 (CTCAE v4)	3 Participants
Summary of Treatment-related Adverse Events Fatigue · Grade 2 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Fatigue · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Fatigue · Subject did not experience this treatment-related toxicity	8 Participants
Summary of Treatment-related Adverse Events Fever · Grade 1 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Fever · Grade 2 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Fever · Grade 3 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Fever · Subject did not experience this treatment-related toxicity	10 Participants
Summary of Treatment-related Adverse Events Paronychia · Grade 1 (CTCAE v4)	2 Participants
Summary of Treatment-related Adverse Events Paronychia · Grade 2 (CTCAE v4)	2 Participants
Summary of Treatment-related Adverse Events Paronychia · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Paronychia · Subject did not experience this treatment-related toxicity	7 Participants
Summary of Treatment-related Adverse Events Alanine aminotransferase increased · Grade 1 (CTCAE v4)	3 Participants
Summary of Treatment-related Adverse Events Alanine aminotransferase increased · Grade 2 (CTCAE v4)	2 Participants
Summary of Treatment-related Adverse Events Alanine aminotransferase increased · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Alanine aminotransferase increased · Subject did not experience this treatment-related toxicity	6 Participants
Summary of Treatment-related Adverse Events Aspartate aminotransferase increased · Grade 1 (CTCAE v4)	4 Participants
Summary of Treatment-related Adverse Events Aspartate aminotransferase increased · Grade 2 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Aspartate aminotransferase increased · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Aspartate aminotransferase increased · Subject did not experience this treatment-related toxicity	7 Participants
Summary of Treatment-related Adverse Events Electrocardiogram QT corrected interval prolonged · Grade 1 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Electrocardiogram QT corrected interval prolonged · Grade 2 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Electrocardiogram QT corrected interval prolonged · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Electrocardiogram QT corrected interval prolonged · Subject did not experience this treatment-related toxicity	10 Participants
Summary of Treatment-related Adverse Events Neutrophil count decreased · Grade 1 (CTCAE v4)	2 Participants
Summary of Treatment-related Adverse Events Neutrophil count decreased · Grade 2 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Neutrophil count decreased · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Neutrophil count decreased · Subject did not experience this treatment-related toxicity	9 Participants
Summary of Treatment-related Adverse Events Weight gain · Grade 1 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Weight gain · Subject did not experience this treatment-related toxicity	10 Participants
Summary of Treatment-related Adverse Events Anorexia · Grade 1 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Hypomagnesemia · Grade 1 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Hypomagnesemia · Grade 2 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Hyponatremia · Grade 2 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Arthralgia · Subject did not experience this treatment-related toxicity	10 Participants
Summary of Treatment-related Adverse Events Erectile dysfunction · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Cough · Subject did not experience this treatment-related toxicity	10 Participants
Summary of Treatment-related Adverse Events Pain of skin · Grade 1 (CTCAE v4)	1 Participants
Summary of Treatment-related Adverse Events Pain of skin · Grade 3 (CTCAE v4)	0 Participants
Summary of Treatment-related Adverse Events Rash acneiform · Grade 1 (CTCAE v4)	5 Participants
Summary of Treatment-related Adverse Events Rash acneiform · Subject did not experience this treatment-related toxicity	4 Participants
Summary of Treatment-related Adverse Events Rash maculo-papular · Subject did not experience this treatment-related toxicity	3 Participants
Summary of Treatment-related Adverse Events Scalp pain · Subject did not experience this treatment-related toxicity	10 Participants

Adverse Events

EGF816 + Gefitinib

Serious events: 2 serious events

Other events: 11 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	EGF816 + Gefitinib n=11 participants at risk * All patients will receive gefitinib orally once daily * EGF816 will be administered orally once daily * Participant will be requested to maintain a medication diary of each dose of medication EGF816: EGF816 is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplying Gefitinib: Gefitinib is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplying
General disorders Fever	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Cardiac disorders Pericardial effusion	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.

Other adverse events

Other adverse events
Measure	EGF816 + Gefitinib n=11 participants at risk * All patients will receive gefitinib orally once daily * EGF816 will be administered orally once daily * Participant will be requested to maintain a medication diary of each dose of medication EGF816: EGF816 is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplying Gefitinib: Gefitinib is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplying
Gastrointestinal disorders Abdominal pain	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Investigations Alanine aminotransferase increased	45.5% 5/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Immune system disorders Allergic reaction	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Skin and subcutaneous tissue disorders Alopecia	18.2% 2/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Blood and lymphatic system disorders Anemia	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Metabolism and nutrition disorders Anorexia	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Psychiatric disorders Anxiety	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Musculoskeletal and connective tissue disorders Arthralgia	18.2% 2/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Musculoskeletal and connective tissue disorders Arthritis	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Investigations Aspartate aminotransferase increased	36.4% 4/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Musculoskeletal and connective tissue disorders Back pain	36.4% 4/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Gastrointestinal disorders Bloating	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify: Hyperlipidemia	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify: Deep Vein Thrombosis	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Investigations Blood bilirubin increased	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Musculoskeletal and connective tissue disorders Bone pain	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Reproductive system and breast disorders Breast pain	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Skin and subcutaneous tissue disorders Bullous dermatitis	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Cardiac disorders Cardiac disorders - Other, specify: heartburn	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Cardiac disorders Cardiac disorders - Other, specify: Papillary Fibroelastoma of the Heart	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Cardiac disorders Cardiac disorders - Other, specify: Prolonged QT	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Cardiac disorders Chest pain - cardiac	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Musculoskeletal and connective tissue disorders Chest wall pain	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
General disorders Chills	27.3% 3/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Investigations Cholesterol high	18.2% 2/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Nervous system disorders Cognitive disturbance	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Respiratory, thoracic and mediastinal disorders Cough	54.5% 6/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Investigations Creatinine increased	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Nervous system disorders Depressed level of consciousness	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Psychiatric disorders Depression	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Gastrointestinal disorders Diarrhea	100.0% 11/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Nervous system disorders Dizziness	18.2% 2/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Eye disorders Dry eye	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Gastrointestinal disorders Dry mouth	36.4% 4/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Skin and subcutaneous tissue disorders Dry skin	45.5% 5/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Gastrointestinal disorders Dyspepsia	18.2% 2/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	63.6% 7/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Investigations Electrocardiogram QT corrected interval prolonged	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Respiratory, thoracic and mediastinal disorders Epistaxis	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Reproductive system and breast disorders Erectile dysfunction	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Skin and subcutaneous tissue disorders Erythema multiforme	18.2% 2/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Eye disorders Eye pain	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
General disorders Fatigue	54.5% 6/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
General disorders Fever	45.5% 5/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Eye disorders Floaters	18.2% 2/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Gastrointestinal disorders Gastroesophageal reflux disease	27.3% 3/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify: mouth sores	18.2% 2/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
General disorders General disorders and administration site conditions - Other, specify: Lisinopril allergy	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Metabolism and nutrition disorders Glucose intolerance	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Nervous system disorders Headache	18.2% 2/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Respiratory, thoracic and mediastinal disorders Hoarseness	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Vascular disorders Hot flashes	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Metabolism and nutrition disorders Hyperglycemia	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Metabolism and nutrition disorders Hyperkalemia	18.2% 2/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Vascular disorders Hypertension	45.5% 5/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Metabolism and nutrition disorders Hypokalemia	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Metabolism and nutrition disorders Hypomagnesemia	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Metabolism and nutrition disorders Hyponatremia	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Endocrine disorders Hypothyroidism	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Immune system disorders Immune system disorders - Other, specify: Environmental Allergy	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Psychiatric disorders Insomnia	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Blood and lymphatic system disorders Leukocytosis	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify: Decrease Appetite	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Gastrointestinal disorders Mucositis oral	27.3% 3/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify: Right Knee Strain	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify: Right hip discomfort	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify: numbness	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify: muscle cramps	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify: Sciatica	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Musculoskeletal and connective tissue disorders Myalgia	27.3% 3/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Gastrointestinal disorders Nausea	18.2% 2/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
General disorders Neck edema	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Musculoskeletal and connective tissue disorders Neck pain	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Investigations Neutrophil count decreased	18.2% 2/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
General disorders Non-cardiac chest pain	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Gastrointestinal disorders Oral pain	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
General disorders Pain	18.2% 2/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Musculoskeletal and connective tissue disorders Pain in extremity	27.3% 3/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Skin and subcutaneous tissue disorders Pain of skin	27.3% 3/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Nervous system disorders Paresthesia	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Infections and infestations Paronychia	36.4% 4/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Cardiac disorders Pericardial tamponade	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Nervous system disorders Peripheral motor neuropathy	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Respiratory, thoracic and mediastinal disorders Pleural effusion	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Respiratory, thoracic and mediastinal disorders Pneumonitis	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Respiratory, thoracic and mediastinal disorders Postnasal drip	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Skin and subcutaneous tissue disorders Pruritus	45.5% 5/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Skin and subcutaneous tissue disorders Rash acneiform	63.6% 7/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Skin and subcutaneous tissue disorders Rash maculo-papular	72.7% 8/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Renal and urinary disorders Renal and urinary disorders - Other, specify: Dysuria	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - other, specify: Asthma	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders: other: Chronic Obstructive Pulmonary Disease	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Skin and subcutaneous tissue disorders Scalp pain	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Cardiac disorders Sinus bradycardia	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Skin and subcutaneous tissue disorders Skin/subcutaneous tissue disorders; Other, specify: Blister on right toe	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Skin and subcutaneous tissue disorders Skin/subcutaneous tissue disorders; Other, specify: Angular Cheilitis	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Skin and subcutaneous tissue disorders Skin/subcutaneous tissue disorders; Other, specify: Tenderness and redness of left fourth finger	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Skin and subcutaneous tissue disorders Skin/subcutaneous tissue disorders; Other, specify: cracks of the fingertips	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Skin and subcutaneous tissue disorders Skin/subcutaneous tissue disorders; Other, specify: Hypersensitivity	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Respiratory, thoracic and mediastinal disorders Sore throat	18.2% 2/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Nervous system disorders Syncope	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Reproductive system and breast disorders Vaginal Pain	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.
Investigations Weight gain	9.1% 1/11 • Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years.

Additional Information

Zofia Piotrowska, MD

Massachusetts General Hospital

Phone: 6176439707

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place