Trial Outcomes & Findings for A Phase 2, Study of Ficlatuzumab Plus Erlotinib vs. Placebo Plus Erlotinib in Subjects With Previously Untreated Metastatic, EGFR-mutated NSCLC and BDX004 Positive Label (NCT NCT02318368)
NCT ID: NCT02318368
Last Updated: 2020-10-22
Results Overview
Progression Free Survival is defined as the time from the date of randomization to the date of the first objective documentation of radiographic disease progression or death due to any cause, whichever occurs first.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Approximately 24 months
Results posted on
2020-10-22
Participant Flow
Subjects who met all the inclusion and none of the exclusion criteria were enrolled in 9 sites in the United States, Australia, Hong Kong, Italy, Singapore, Korea, and Taiwan. The Sponsor terminated Study AV-299-14-206, effective 14-Sep-2016, after determining that enrollment of participants was much lower than expected.
Prior to screening, subjects who have tested positive for a sensitizing Epidermal growth factor receptor (EGFR) mutation to determine eligibility for treatment with erlotinib. All participants underwent inclusion exclusion criteria assessment and all eligible participants signed the informed consent before undergoing any study-related procedures.
Participant milestones
| Measure |
Ficlatuzumab Plus Erlotinib
Participants received 150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with 20 mg/kg Ficlatuzumab administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.
|
Placebo Plus Erlotinib
Participants received 150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with Placebo administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
| Measure |
Ficlatuzumab Plus Erlotinib
Participants received 150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with 20 mg/kg Ficlatuzumab administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.
|
Placebo Plus Erlotinib
Participants received 150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with Placebo administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Study terminated by the sponsor
|
5
|
2
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
A Phase 2, Study of Ficlatuzumab Plus Erlotinib vs. Placebo Plus Erlotinib in Subjects With Previously Untreated Metastatic, EGFR-mutated NSCLC and BDX004 Positive Label
Baseline characteristics by cohort
| Measure |
Ficlatuzumab Plus Erlotinib
n=7 Participants
Participants received 150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with 20 mg/kg Ficlatuzumab administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.
|
Placebo Plus Erlotinib
n=3 Participants
Participants received 150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with Placebo administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Approximately 24 monthsPopulation: The study was terminated prior to completing enrollment; after determining that enrollment of subjects was much lower than expected, no data was collected for this outcome measure.
Progression Free Survival is defined as the time from the date of randomization to the date of the first objective documentation of radiographic disease progression or death due to any cause, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 24 monthsPopulation: All participants who received one dose of study drug
To evaluate Safety and tolerability of ficlatuzumab plus erlotinib versus placebo plus erlotinib in subjects who have previously untreated metastatic EGFR-mutated NSCLC and a BDX004 Positive Label.
Outcome measures
| Measure |
Ficlatuzumab Plus Erlotinib
n=7 Participants
Participants received 150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with 20 mg/kg Ficlatuzumab administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.
|
Placebo Plus Erlotinib
n=3 Participants
Participants received 150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with Placebo administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.
|
|---|---|---|
|
Number of Participants With Adverse Events
Patients with Treatment-Emergent Adverse Events
|
7 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events
Patients with Serious Adverse Events
|
3 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Patients with grade 5 TEAEs
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Patients with grade 3 or 4 TEAEs
|
4 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Patients permanently discontinued
|
2 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Patients with dose reduction or interruption
|
3 Participants
|
0 Participants
|
Adverse Events
Ficlatuzumab Plus Erlotinib
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo Plus Erlotinib
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Ficlatuzumab Plus Erlotinib
n=7 participants at risk
Participants received 150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with 20 mg/kg Ficlatuzumab administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.
|
Placebo Plus Erlotinib
n=3 participants at risk
Participants received 150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with Placebo administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.
|
|---|---|---|
|
Vascular disorders
Deep vein thrombosis
|
14.3%
1/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
0.00%
0/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
14.3%
1/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
0.00%
0/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
14.3%
1/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
0.00%
0/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Metabolism and nutrition disorders
Fluid overload
|
14.3%
1/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
0.00%
0/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
14.3%
1/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
0.00%
0/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
14.3%
1/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
0.00%
0/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
33.3%
1/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
Other adverse events
| Measure |
Ficlatuzumab Plus Erlotinib
n=7 participants at risk
Participants received 150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with 20 mg/kg Ficlatuzumab administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.
|
Placebo Plus Erlotinib
n=3 participants at risk
Participants received 150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with Placebo administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
71.4%
5/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
66.7%
2/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
28.6%
2/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
66.7%
2/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
28.6%
2/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
33.3%
1/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.3%
1/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
0.00%
0/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
14.3%
1/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
0.00%
0/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
14.3%
1/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
0.00%
0/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
14.3%
1/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
0.00%
0/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Skin and subcutaneous tissue disorders
Papule
|
14.3%
1/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
0.00%
0/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
14.3%
1/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
0.00%
0/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
14.3%
1/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
0.00%
0/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
33.3%
1/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
28.6%
2/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
100.0%
3/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Gastrointestinal disorders
Nausea
|
28.6%
2/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
0.00%
0/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Gastrointestinal disorders
Mouth ulceration
|
14.3%
1/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
33.3%
1/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Gastrointestinal disorders
Abdominal distension
|
14.3%
1/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
0.00%
0/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
0.00%
0/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
14.3%
1/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
0.00%
0/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Gastrointestinal disorders
Oral pain
|
14.3%
1/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
0.00%
0/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
33.3%
1/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
33.3%
1/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
33.3%
1/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
33.3%
1/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Infections and infestations
Paronychia
|
14.3%
1/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
33.3%
1/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Infections and infestations
Nail infection
|
14.3%
1/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
0.00%
0/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Infections and infestations
Nasopharyngitis
|
14.3%
1/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
0.00%
0/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Infections and infestations
Oral candidiasis
|
14.3%
1/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
0.00%
0/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
33.3%
1/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
28.6%
2/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
0.00%
0/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.3%
1/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
0.00%
0/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
33.3%
1/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory gas exchange disorder
|
0.00%
0/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
33.3%
1/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
1/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
33.3%
1/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
33.3%
1/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
General disorders
Mucosal inflammation
|
14.3%
1/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
0.00%
0/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
General disorders
Peripheral swelling
|
0.00%
0/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
33.3%
1/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
1/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
0.00%
0/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
33.3%
1/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
33.3%
1/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
33.3%
1/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
33.3%
1/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
33.3%
1/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
|
Reproductive system and breast disorders
Pelvic fluid collection
|
0.00%
0/7 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
33.3%
1/3 • Approximately 24 months
An AEs is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In addition abnormal findings in vitals signs, resting 12-lead pECGs (electrocardiography), continuous dECGs, cardiac telemetry and spirometry were reported as AEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place