Trial Outcomes & Findings for An Open Label Phase II Trial of BIBW 2992 in Patients With HER2-negative Metastatic Breast Cancer (NCT NCT00425854)

NCT ID: NCT00425854

Last Updated: 2013-12-31

Results Overview

OR is defined as complete response (CR) and partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST). OR was primary endpoint only for Cohort B.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
• Results posted on: 2013-12-31

Participant Flow

Participant milestones

Measure	Cohort A Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)	Cohort B Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
Overall Study STARTED	29	21
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	29	21

Reasons for withdrawal

Measure	Cohort A Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)	Cohort B Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
Overall Study Progressive Disease	19	12
Overall Study Dose reduction toxicity AE	8	7
Overall Study Other Adverse Event	2	2

Baseline Characteristics

An Open Label Phase II Trial of BIBW 2992 in Patients With HER2-negative Metastatic Breast Cancer

Baseline characteristics by cohort

Measure	Cohort A n=29 Participants Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)	Cohort B n=21 Participants Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd	Total n=50 Participants Total of all reporting groups
Age, Continuous	54.3 years STANDARD_DEVIATION 11.5 • n=5 Participants	61.0 years STANDARD_DEVIATION 14.3 • n=7 Participants	57.1 years STANDARD_DEVIATION 13.0 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	21 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.

Population: Treated Set (TS). TS consisted of all patients who received at least one dose of trial medication. No data for Cohort A as OR was primary endpoint only for Cohort B.

OR is defined as complete response (CR) and partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST). OR was primary endpoint only for Cohort B.

Outcome measures

Measure	Cohort B n=21 Participants Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd	Cohort B Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
Objective Response (OR)	0 Participants with OR	—

PRIMARY outcome

Timeframe: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.

Population: TS. No data for Cohort B as CB was primary endpoint only for Cohort A.

CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was primary endpoint only for Cohort A.

Outcome measures

Measure	Cohort B n=29 Participants Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd	Cohort B Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
Clinical Benefit (CB) With CB	3 Participants	—
Clinical Benefit (CB) Without CB	24 Participants	—
Clinical Benefit (CB) missing	2 Participants	—

SECONDARY outcome

Timeframe: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.

Population: TS. No data for Cohort A as CB was secondary endpoint only for Cohort B.

CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was secondary endpoint only for Cohort B as it was primary endpoint for Cohort A.

Outcome measures

Measure	Cohort B n=21 Participants Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd	Cohort B Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
Clinical Benefit (CB) With CB	1 Participants with CB	—
Clinical Benefit (CB) Without CB	17 Participants with CB	—
Clinical Benefit (CB) missing	3 Participants with CB	—

SECONDARY outcome

Timeframe: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.

Population: TS. Median time to OR was not calcuable as there was no OR observed.

The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.0 criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.

Population: TS. Median duration of OR was not calcuable as there was no OR observed.

Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.

Population: TS

PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to RECIST 1.0 criteria as well as by the investigators assessment. Median time results from unstratified Kaplan-Meier estimates.

Outcome measures

Measure	Cohort B n=29 Participants Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd	Cohort B n=21 Participants Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
Progression-free Survival (PFS)	52 days Interval 39.0 to 71.0	54 days Interval 50.0 to 112.0

SECONDARY outcome

Timeframe: From randomisation to end of follow-up.

Population: TS. As only 9 patient (31 percent) of Cohort A had died the median OS time was not estimable for Cohort A.

OS is defined as time from randomisation to death.

Outcome measures

Measure	Cohort B n=29 Participants Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd	Cohort B n=21 Participants Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
Overall Survival (OS)	NA days Interval 120.0 to The 95% confidence interval is actually 120 to infinity, a median is not available.	448 days Interval 310.0 to 537.0

SECONDARY outcome

Timeframe: Baseline and last assessment

Population: TS

LVEF as measured by echocardiography or Multiple Gated Acquisition (MUGA) scan. MUGA scan is an useful noninvasive tool for assessing the function of the heart. Significant change in LVEF values was defined as >=20 percent decrease from baseline or to below lower limit of normal, which was defined as 50 percent.

Outcome measures

Measure	Cohort B n=29 Participants Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd	Cohort B n=21 Participants Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
Significant Change in Cardiac Left Ventricular Ejection Fraction (LVEF)	1 Participants	2 Participants

SECONDARY outcome

Timeframe: baseline till end of treatment

Best change from baseline in ECOG (Eastern Cooperative Oncology Group) performance status. ECOG is measured as score between 0 (fully active) and 5 (dead).

Outcome measures

Measure	Cohort B n=29 Participants Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd	Cohort B n=21 Participants Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
Best Change From Baseline in ECOG Performance Status improved	1 participants	0 participants
Best Change From Baseline in ECOG Performance Status deteriorated	15 participants	13 participants

SECONDARY outcome

Timeframe: day 29

Cpre,ss,29 represents the pre-dose concentration of afatinib in plasma at steady state on day 29.

Outcome measures

Measure	Cohort B n=10 Participants Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd	Cohort B n=6 Participants Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 29 (Cpre,ss,29)	33.1 ng/mL Geometric Coefficient of Variation 110	22.9 ng/mL Geometric Coefficient of Variation 64.7

Adverse Events

Cohort A

Serious events: 13 serious events

Other events: 28 other events

Deaths: 0 deaths

Cohort B

Serious events: 7 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cohort A n=29 participants at risk Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)	Cohort B n=21 participants at risk Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
Blood and lymphatic system disorders Anaemia	3.4% 1/29 • First administration of trial medication until 28 days after last administration of trial medication	0.00% 0/21 • First administration of trial medication until 28 days after last administration of trial medication
Blood and lymphatic system disorders Febrile neutropenia	3.4% 1/29 • First administration of trial medication until 28 days after last administration of trial medication	0.00% 0/21 • First administration of trial medication until 28 days after last administration of trial medication
Ear and labyrinth disorders Meniere's disease	3.4% 1/29 • First administration of trial medication until 28 days after last administration of trial medication	0.00% 0/21 • First administration of trial medication until 28 days after last administration of trial medication
Eye disorders Eyelid ptosis	3.4% 1/29 • First administration of trial medication until 28 days after last administration of trial medication	0.00% 0/21 • First administration of trial medication until 28 days after last administration of trial medication
Eye disorders Miosis	3.4% 1/29 • First administration of trial medication until 28 days after last administration of trial medication	0.00% 0/21 • First administration of trial medication until 28 days after last administration of trial medication
Gastrointestinal disorders Abdominal pain	0.00% 0/29 • First administration of trial medication until 28 days after last administration of trial medication	4.8% 1/21 • First administration of trial medication until 28 days after last administration of trial medication
Gastrointestinal disorders Diarrhoea	10.3% 3/29 • First administration of trial medication until 28 days after last administration of trial medication	9.5% 2/21 • First administration of trial medication until 28 days after last administration of trial medication
Gastrointestinal disorders Dysphagia	0.00% 0/29 • First administration of trial medication until 28 days after last administration of trial medication	4.8% 1/21 • First administration of trial medication until 28 days after last administration of trial medication
Gastrointestinal disorders Nausea	0.00% 0/29 • First administration of trial medication until 28 days after last administration of trial medication	9.5% 2/21 • First administration of trial medication until 28 days after last administration of trial medication
Gastrointestinal disorders Oesophageal stenosis	0.00% 0/29 • First administration of trial medication until 28 days after last administration of trial medication	4.8% 1/21 • First administration of trial medication until 28 days after last administration of trial medication
Gastrointestinal disorders Vomiting	6.9% 2/29 • First administration of trial medication until 28 days after last administration of trial medication	0.00% 0/21 • First administration of trial medication until 28 days after last administration of trial medication
General disorders Fatigue	0.00% 0/29 • First administration of trial medication until 28 days after last administration of trial medication	4.8% 1/21 • First administration of trial medication until 28 days after last administration of trial medication
General disorders General physical health deterioration	17.2% 5/29 • First administration of trial medication until 28 days after last administration of trial medication	0.00% 0/21 • First administration of trial medication until 28 days after last administration of trial medication
General disorders Mucosal inflammation	0.00% 0/29 • First administration of trial medication until 28 days after last administration of trial medication	4.8% 1/21 • First administration of trial medication until 28 days after last administration of trial medication
General disorders Pain	0.00% 0/29 • First administration of trial medication until 28 days after last administration of trial medication	4.8% 1/21 • First administration of trial medication until 28 days after last administration of trial medication
General disorders Pyrexia	0.00% 0/29 • First administration of trial medication until 28 days after last administration of trial medication	4.8% 1/21 • First administration of trial medication until 28 days after last administration of trial medication
Hepatobiliary disorders Bile duct obstruction	3.4% 1/29 • First administration of trial medication until 28 days after last administration of trial medication	0.00% 0/21 • First administration of trial medication until 28 days after last administration of trial medication
Hepatobiliary disorders Jaundice	3.4% 1/29 • First administration of trial medication until 28 days after last administration of trial medication	0.00% 0/21 • First administration of trial medication until 28 days after last administration of trial medication
Infections and infestations Abscess rupture	3.4% 1/29 • First administration of trial medication until 28 days after last administration of trial medication	0.00% 0/21 • First administration of trial medication until 28 days after last administration of trial medication
Infections and infestations Bronchopneumonia	3.4% 1/29 • First administration of trial medication until 28 days after last administration of trial medication	0.00% 0/21 • First administration of trial medication until 28 days after last administration of trial medication
Investigations Hepatic enzyme increased	0.00% 0/29 • First administration of trial medication until 28 days after last administration of trial medication	4.8% 1/21 • First administration of trial medication until 28 days after last administration of trial medication
Metabolism and nutrition disorders Dehydration	6.9% 2/29 • First administration of trial medication until 28 days after last administration of trial medication	4.8% 1/21 • First administration of trial medication until 28 days after last administration of trial medication
Metabolism and nutrition disorders Hypokalaemia	3.4% 1/29 • First administration of trial medication until 28 days after last administration of trial medication	0.00% 0/21 • First administration of trial medication until 28 days after last administration of trial medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	6.9% 2/29 • First administration of trial medication until 28 days after last administration of trial medication	9.5% 2/21 • First administration of trial medication until 28 days after last administration of trial medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic pain	3.4% 1/29 • First administration of trial medication until 28 days after last administration of trial medication	0.00% 0/21 • First administration of trial medication until 28 days after last administration of trial medication
Nervous system disorders Peripheral motor neuropathy	0.00% 0/29 • First administration of trial medication until 28 days after last administration of trial medication	4.8% 1/21 • First administration of trial medication until 28 days after last administration of trial medication
Nervous system disorders VIth nerve paralysis	3.4% 1/29 • First administration of trial medication until 28 days after last administration of trial medication	0.00% 0/21 • First administration of trial medication until 28 days after last administration of trial medication
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/29 • First administration of trial medication until 28 days after last administration of trial medication	4.8% 1/21 • First administration of trial medication until 28 days after last administration of trial medication
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/29 • First administration of trial medication until 28 days after last administration of trial medication	4.8% 1/21 • First administration of trial medication until 28 days after last administration of trial medication
Skin and subcutaneous tissue disorders Rash	0.00% 0/29 • First administration of trial medication until 28 days after last administration of trial medication	4.8% 1/21 • First administration of trial medication until 28 days after last administration of trial medication

Other adverse events

Measure	Cohort A n=29 participants at risk Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)	Cohort B n=21 participants at risk Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
Blood and lymphatic system disorders Anaemia	6.9% 2/29 • First administration of trial medication until 28 days after last administration of trial medication	0.00% 0/21 • First administration of trial medication until 28 days after last administration of trial medication
Ear and labyrinth disorders Vertigo	6.9% 2/29 • First administration of trial medication until 28 days after last administration of trial medication	0.00% 0/21 • First administration of trial medication until 28 days after last administration of trial medication
Eye disorders Blepharitis	0.00% 0/29 • First administration of trial medication until 28 days after last administration of trial medication	9.5% 2/21 • First administration of trial medication until 28 days after last administration of trial medication
Eye disorders Conjunctivitis	6.9% 2/29 • First administration of trial medication until 28 days after last administration of trial medication	9.5% 2/21 • First administration of trial medication until 28 days after last administration of trial medication
Gastrointestinal disorders Abdominal pain	10.3% 3/29 • First administration of trial medication until 28 days after last administration of trial medication	0.00% 0/21 • First administration of trial medication until 28 days after last administration of trial medication
Gastrointestinal disorders Diarrhoea	86.2% 25/29 • First administration of trial medication until 28 days after last administration of trial medication	76.2% 16/21 • First administration of trial medication until 28 days after last administration of trial medication
Gastrointestinal disorders Dysphagia	3.4% 1/29 • First administration of trial medication until 28 days after last administration of trial medication	9.5% 2/21 • First administration of trial medication until 28 days after last administration of trial medication
Gastrointestinal disorders Nausea	44.8% 13/29 • First administration of trial medication until 28 days after last administration of trial medication	23.8% 5/21 • First administration of trial medication until 28 days after last administration of trial medication
Gastrointestinal disorders Oral pain	6.9% 2/29 • First administration of trial medication until 28 days after last administration of trial medication	4.8% 1/21 • First administration of trial medication until 28 days after last administration of trial medication
Gastrointestinal disorders Stomatitis	17.2% 5/29 • First administration of trial medication until 28 days after last administration of trial medication	9.5% 2/21 • First administration of trial medication until 28 days after last administration of trial medication
Gastrointestinal disorders Vomiting	13.8% 4/29 • First administration of trial medication until 28 days after last administration of trial medication	28.6% 6/21 • First administration of trial medication until 28 days after last administration of trial medication
General disorders Fatigue	31.0% 9/29 • First administration of trial medication until 28 days after last administration of trial medication	33.3% 7/21 • First administration of trial medication until 28 days after last administration of trial medication
General disorders Mucosal inflammation	31.0% 9/29 • First administration of trial medication until 28 days after last administration of trial medication	28.6% 6/21 • First administration of trial medication until 28 days after last administration of trial medication
General disorders Pain	3.4% 1/29 • First administration of trial medication until 28 days after last administration of trial medication	9.5% 2/21 • First administration of trial medication until 28 days after last administration of trial medication
Investigations Weight decreased	10.3% 3/29 • First administration of trial medication until 28 days after last administration of trial medication	0.00% 0/21 • First administration of trial medication until 28 days after last administration of trial medication
Metabolism and nutrition disorders Decreased appetite	27.6% 8/29 • First administration of trial medication until 28 days after last administration of trial medication	28.6% 6/21 • First administration of trial medication until 28 days after last administration of trial medication
Metabolism and nutrition disorders Hypokalaemia	3.4% 1/29 • First administration of trial medication until 28 days after last administration of trial medication	9.5% 2/21 • First administration of trial medication until 28 days after last administration of trial medication
Musculoskeletal and connective tissue disorders Arthralgia	10.3% 3/29 • First administration of trial medication until 28 days after last administration of trial medication	0.00% 0/21 • First administration of trial medication until 28 days after last administration of trial medication
Nervous system disorders Dysgeusia	6.9% 2/29 • First administration of trial medication until 28 days after last administration of trial medication	9.5% 2/21 • First administration of trial medication until 28 days after last administration of trial medication
Nervous system disorders Headache	6.9% 2/29 • First administration of trial medication until 28 days after last administration of trial medication	0.00% 0/21 • First administration of trial medication until 28 days after last administration of trial medication
Nervous system disorders Paraesthesia	6.9% 2/29 • First administration of trial medication until 28 days after last administration of trial medication	0.00% 0/21 • First administration of trial medication until 28 days after last administration of trial medication
Psychiatric disorders Insomnia	6.9% 2/29 • First administration of trial medication until 28 days after last administration of trial medication	0.00% 0/21 • First administration of trial medication until 28 days after last administration of trial medication
Respiratory, thoracic and mediastinal disorders Cough	3.4% 1/29 • First administration of trial medication until 28 days after last administration of trial medication	14.3% 3/21 • First administration of trial medication until 28 days after last administration of trial medication
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.3% 3/29 • First administration of trial medication until 28 days after last administration of trial medication	14.3% 3/21 • First administration of trial medication until 28 days after last administration of trial medication
Respiratory, thoracic and mediastinal disorders Epistaxis	20.7% 6/29 • First administration of trial medication until 28 days after last administration of trial medication	19.0% 4/21 • First administration of trial medication until 28 days after last administration of trial medication
Respiratory, thoracic and mediastinal disorders Nasal dryness	6.9% 2/29 • First administration of trial medication until 28 days after last administration of trial medication	4.8% 1/21 • First administration of trial medication until 28 days after last administration of trial medication
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.4% 1/29 • First administration of trial medication until 28 days after last administration of trial medication	14.3% 3/21 • First administration of trial medication until 28 days after last administration of trial medication
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	6.9% 2/29 • First administration of trial medication until 28 days after last administration of trial medication	4.8% 1/21 • First administration of trial medication until 28 days after last administration of trial medication
Skin and subcutaneous tissue disorders Acne	37.9% 11/29 • First administration of trial medication until 28 days after last administration of trial medication	14.3% 3/21 • First administration of trial medication until 28 days after last administration of trial medication
Skin and subcutaneous tissue disorders Dermatitis acneiform	3.4% 1/29 • First administration of trial medication until 28 days after last administration of trial medication	14.3% 3/21 • First administration of trial medication until 28 days after last administration of trial medication
Skin and subcutaneous tissue disorders Dry skin	27.6% 8/29 • First administration of trial medication until 28 days after last administration of trial medication	19.0% 4/21 • First administration of trial medication until 28 days after last administration of trial medication
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	3.4% 1/29 • First administration of trial medication until 28 days after last administration of trial medication	23.8% 5/21 • First administration of trial medication until 28 days after last administration of trial medication
Skin and subcutaneous tissue disorders Pruritus	10.3% 3/29 • First administration of trial medication until 28 days after last administration of trial medication	4.8% 1/21 • First administration of trial medication until 28 days after last administration of trial medication
Skin and subcutaneous tissue disorders Rash	31.0% 9/29 • First administration of trial medication until 28 days after last administration of trial medication	47.6% 10/21 • First administration of trial medication until 28 days after last administration of trial medication
Skin and subcutaneous tissue disorders Skin fissures	6.9% 2/29 • First administration of trial medication until 28 days after last administration of trial medication	14.3% 3/21 • First administration of trial medication until 28 days after last administration of trial medication
Skin and subcutaneous tissue disorders Xeroderma	0.00% 0/29 • First administration of trial medication until 28 days after last administration of trial medication	9.5% 2/21 • First administration of trial medication until 28 days after last administration of trial medication
Vascular disorders Hypertension	10.3% 3/29 • First administration of trial medication until 28 days after last administration of trial medication	0.00% 0/21 • First administration of trial medication until 28 days after last administration of trial medication

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

• Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication
• Publication restrictions are in place

Restriction type: OTHER