Trial Outcomes & Findings for LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research (NCT NCT02231164)
NCT ID: NCT02231164
Last Updated: 2025-02-13
Results Overview
This outcome measure presents the number of patients with disease control according to RECIST, version 1.1, defined as number of patients with Complete response, partial response or stable disease.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
12 participants
Primary outcome timeframe
Up to 6 months.
Results posted on
2025-02-13
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m\^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
Nintedanib
Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m\^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m\^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
Nintedanib
Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m\^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research
Baseline characteristics by cohort
| Measure |
Placebo
n=6 Participants
Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m\^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
Nintedanib
n=6 Participants
Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m\^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.7 Years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
63.3 Years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
61.5 Years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 months.Population: Randomised Set: The randomised set included all randomised patients.
This outcome measure presents the number of patients with disease control according to RECIST, version 1.1, defined as number of patients with Complete response, partial response or stable disease.
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m\^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
Nintedanib
n=6 Participants
Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m\^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
|---|---|---|
|
Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1
No
|
33.3 Percentage of participants
|
50.0 Percentage of participants
|
|
Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1
Yes
|
66.7 Percentage of participants
|
50.0 Percentage of participants
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Nintedanib
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=6 participants at risk
Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m\^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
Nintedanib
n=6 participants at risk
Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m\^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Cardiac disorders
Atrial fibrillation
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Cardiac disorders
Tachycardia
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Infections and infestations
Clostridium difficile infection
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to skin
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Vascular disorders
Orthostatic hypotension
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
Other adverse events
| Measure |
Placebo
n=6 participants at risk
Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m\^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
Nintedanib
n=6 participants at risk
Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m\^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Blood and lymphatic system disorders
Leukopenia
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
50.0%
3/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Eye disorders
Lacrimation increased
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Eye disorders
Visual impairment
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
3/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
3/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
66.7%
4/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Gastrointestinal disorders
Glossodynia
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
83.3%
5/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
83.3%
5/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
General disorders
Chest pain
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
General disorders
Chills
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
General disorders
Facial pain
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
General disorders
Fatigue
|
66.7%
4/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
50.0%
3/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
General disorders
Mucosal inflammation
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
General disorders
Oedema peripheral
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
General disorders
Pain
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
General disorders
Polyp
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Infections and infestations
Cellulitis
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Infections and infestations
Pneumonia
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Investigations
Weight decreased
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
66.7%
4/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Nervous system disorders
Neuropathy peripheral
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
50.0%
3/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Nervous system disorders
Syncope
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Psychiatric disorders
Mood altered
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Renal and urinary disorders
Proteinuria
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
3/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
3/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 7 months.
|
Additional Information
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Phone: 1-800-243-0127
Email: [email protected]
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- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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