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Trial record 13 of 19 for:    colon cancer | ( Map: Mexico )

Nintedanib (BIBF 1120) vs Placebo in Refractory Metastatic Colorectal Cancer (LUME-Colon 1)

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ClinicalTrials.gov Identifier: NCT02149108
Recruitment Status : Completed
First Posted : May 29, 2014
Results First Posted : July 21, 2017
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Colorectal Neoplasms
Interventions Drug: Nintedanib (BIBF 1120)
Drug: Placebo
Drug: BSC
Enrollment 768
Recruitment Details

The "completed" patients were on treatment (2 patients on Placebo, 3 patients on Nintedanib) at the data cut-off date 14JUN2016.

The "NOT Completed" patients were off-treatment (380 patients on Placebo, 383 patients on Nintedanib) at the data cut-off date 14JUN2016.

Pre-assignment Details  
Arm/Group Title Placebo Nintedanib
Hide Arm/Group Description Placebo soft gelatin capsule matching that of Nintedanib twice daily (b.i.d.) administered orally of 21-day treatment course. If required the dose of placebo, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction. Nintedanib 200 mg twice daily (b.i.d.) administered orally in the form of a soft gelatin capsule of 21-day treatment course. If required the dose of Nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
Period Title: Overall Study
Started 382 [1] 386 [1]
Completed 2 [2] 3 [2]
Not Completed 380 383
Reason Not Completed
Not treated             1             2
Progressive Disease (PD)             324             318
Worsening/adverse event cancer disease             31             32
Other Adverse Event (AE)             8             18
Other not defined above             0             2
Refusal to continue trial medication             15             11
Lost to Follow-up             1             0
[1]
Randomised patients.
[2]
On-treatment at analysis cut-off date (14JUN2016).
Arm/Group Title Placebo Nintedanib Total
Hide Arm/Group Description Placebo soft gelatin capsule matching that of Nintedanib twice daily (b.i.d.) administered orally of 21-day treatment course. If required the dose of placebo, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction. Nintedanib 200 mg twice daily (b.i.d.) administered orally in the form of a soft gelatin capsule of 21-day treatment course. If required the dose of Nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction. Total of all reporting groups
Overall Number of Baseline Participants 382 386 768
Hide Baseline Analysis Population Description
Randomised Set (RS): This patient set included all patients who were randomised to receive treatment, whether treated or not.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 382 participants 386 participants 768 participants
61.1  (10.8) 61.0  (11.3) 61.1  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 382 participants 386 participants 768 participants
Female
164
  42.9%
150
  38.9%
314
  40.9%
Male
218
  57.1%
236
  61.1%
454
  59.1%
1.Primary Outcome
Title Progression-Free Survival (PFS) by Central Review Assessment
Hide Description

PFS by central review assessment was defined as the time from the date of randomisation to the date of disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 or death from any cause, whichever occurred first.

Median, 95% Confidence Interval were calculated from an unadjusted Kaplan−Meier curve for each treatment arm.

Time Frame From randomisation until cut-off date 14JUN2016.
Hide Outcome Measure Data
Hide Analysis Population Description
Randomised Set: This patient set included all patients who were randomised to receive treatment, whether treated or not.
Arm/Group Title Placebo Nintedanib
Hide Arm/Group Description:
Placebo soft gelatin capsule matching that of Nintedanib twice daily (b.i.d.) administered orally of 21-day treatment course. If required the dose of placebo, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
Nintedanib 200 mg twice daily (b.i.d.) administered orally in the form of a soft gelatin capsule of 21-day treatment course. If required the dose of Nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
Overall Number of Participants Analyzed 382 386
Median (95% Confidence Interval)
Unit of Measure: Months
1.38
(1.38 to 1.41)
1.51
(1.45 to 2.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Nintedanib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Hazard ratio, confidence interval and p−value obtained from log−rank test stratified by regorafenib pre−treatment (yes vs no), time from onset metastatic disease until randomisation (less than 24 months vs 24 months or more ) and region.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
0.49 to 0.69
Estimation Comments Hazard ratio <1 favors Nintedanib.
2.Primary Outcome
Title Overall Survival (OS)
Hide Description

OS was defined as the time from randomisation to the time of death from any cause.

Median, 95% Confidence Interval were calculated from an unadjusted Kaplan−Meier curve for each treatment arm.

Time Frame From randomisation until cut-off date 14JUN2016.
Hide Outcome Measure Data
Hide Analysis Population Description
Randomised Set: This patient set included all patients who were randomised to receive treatment, whether treated or not.
Arm/Group Title Placebo Nintedanib
Hide Arm/Group Description:
Placebo soft gelatin capsule matching that of Nintedanib twice daily (b.i.d.) administered orally of 21-day treatment course. If required the dose of placebo, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
Nintedanib 200 mg twice daily (b.i.d.) administered orally in the form of a soft gelatin capsule of 21-day treatment course. If required the dose of Nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
Overall Number of Participants Analyzed 382 386
Median (95% Confidence Interval)
Unit of Measure: Months
6.05
(5.22 to 6.97)
6.44
(5.98 to 7.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Nintedanib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8659
Comments Hazard ratio, confidence interval and p−value obtained from log−rank test stratified by regorafenib pre−treatment (yes vs no), time from onset metastatic disease until randomisation (less than 24 months vs 24 months or more ) and region.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.86 to 1.19
Estimation Comments Hazard ratio below 1 favors Nintedanib.
3.Secondary Outcome
Title Objective Tumour Response (Complete Response (CR)) + Partial Response (PR) by Central Review Assessment
Hide Description Objective tumour response was defined as best overall response of CR or PR determined by central review assessment.
Time Frame From randomisation until cut-off date 14JUN2016.
Hide Outcome Measure Data
Hide Analysis Population Description
Randomised Set: This patient set included all patients who were randomised to receive treatment, whether treated or not.
Arm/Group Title Placebo Nintedanib
Hide Arm/Group Description:
Placebo soft gelatin capsule matching that of Nintedanib twice daily (b.i.d.) administered orally of 21-day treatment course. If required the dose of placebo, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
Nintedanib 200 mg twice daily (b.i.d.) administered orally in the form of a soft gelatin capsule of 21-day treatment course. If required the dose of Nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
Overall Number of Participants Analyzed 382 386
Measure Type: Number
Unit of Measure: Percentage of participants
0 0
4.Secondary Outcome
Title Disease Control (Complete Response + Partial Response + Stable Disease) by Central Review Assessment
Hide Description Disease control was defined as best overall response of CR, PR, or Stable Disease (SD).
Time Frame From randomisation until cut-off date 14JUN2016.
Hide Outcome Measure Data
Hide Analysis Population Description
Randomised Set: This patient set included all patients who were randomised to receive treatment, whether treated or not.
Arm/Group Title Placebo Nintedanib
Hide Arm/Group Description:
Placebo soft gelatin capsule matching that of Nintedanib twice daily (b.i.d.) administered orally of 21-day treatment course. If required the dose of placebo, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
Nintedanib 200 mg twice daily (b.i.d.) administered orally in the form of a soft gelatin capsule of 21-day treatment course. If required the dose of Nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
Overall Number of Participants Analyzed 382 386
Measure Type: Number
Unit of Measure: Percentage of participants
10.5 25.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Nintedanib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Odds ratio and p−value are obtained from logistic regression model adjusted for regorafenib pre−treatment (yes vs no), time from onset metastatic disease until randomization in the trial (less than 24 months vs. 24 months or more) and region.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.96
Confidence Interval (2-Sided) 95%
2.00 to 4.47
Estimation Comments An odds ratio >1 indicates benefit to Nintedanib.
Time Frame From first drug administration until 28 days after last drug administration, up to 22.7 months.
Adverse Event Reporting Description
  1. patient who was randomised to the Placebo was not treated. Consequently, number of subjects that started is 382 but only 381 reported that includes only treated patients.
  2. patients were randomised to the Nintedanib were not treated. Consequently, number of subjects that started is 386 but only 384 reported that includes only treated patients.
 
Arm/Group Title Placebo Nintedanib
Hide Arm/Group Description Placebo soft gelatin capsule matching that of Nintedanib twice daily (b.i.d.) administered orally of 21-day treatment course. If required the dose of placebo, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction. Nintedanib 200 mg twice daily (b.i.d.) administered orally in the form of a soft gelatin capsule of 21-day treatment course. If required the dose of Nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
All-Cause Mortality
Placebo Nintedanib
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Nintedanib
Affected / at Risk (%) Affected / at Risk (%)
Total   133/381 (34.91%)   149/384 (38.80%) 
Blood and lymphatic system disorders     
Anaemia  1  1/381 (0.26%)  2/384 (0.52%) 
Cardiac disorders     
Atrial fibrillation  1  2/381 (0.52%)  0/384 (0.00%) 
Atrioventricular block complete  1  1/381 (0.26%)  0/384 (0.00%) 
Bradycardia  1  0/381 (0.00%)  1/384 (0.26%) 
Cardiac arrest  1  1/381 (0.26%)  0/384 (0.00%) 
Cardiac failure  1  0/381 (0.00%)  1/384 (0.26%) 
Ear and labyrinth disorders     
Vertigo  1  0/381 (0.00%)  1/384 (0.26%) 
Gastrointestinal disorders     
Abdominal distension  1  4/381 (1.05%)  2/384 (0.52%) 
Abdominal hernia  1  0/381 (0.00%)  1/384 (0.26%) 
Abdominal pain  1  4/381 (1.05%)  6/384 (1.56%) 
Abdominal pain lower  1  1/381 (0.26%)  0/384 (0.00%) 
Abdominal pain upper  1  1/381 (0.26%)  1/384 (0.26%) 
Ascites  1  4/381 (1.05%)  1/384 (0.26%) 
Constipation  1  1/381 (0.26%)  2/384 (0.52%) 
Diarrhoea  1  2/381 (0.52%)  2/384 (0.52%) 
Dysphagia  1  1/381 (0.26%)  2/384 (0.52%) 
Enterocutaneous fistula  1  0/381 (0.00%)  1/384 (0.26%) 
Fistula of small intestine  1  1/381 (0.26%)  0/384 (0.00%) 
Gastrointestinal haemorrhage  1  1/381 (0.26%)  0/384 (0.00%) 
Gastrointestinal hypomotility  1  0/381 (0.00%)  1/384 (0.26%) 
Ileus  1  2/381 (0.52%)  5/384 (1.30%) 
Incarcerated inguinal hernia  1  0/381 (0.00%)  2/384 (0.52%) 
Intestinal obstruction  1  6/381 (1.57%)  6/384 (1.56%) 
Intestinal prolapse  1  0/381 (0.00%)  1/384 (0.26%) 
Large intestinal obstruction  1  0/381 (0.00%)  1/384 (0.26%) 
Large intestinal stenosis  1  0/381 (0.00%)  1/384 (0.26%) 
Large intestine perforation  1  0/381 (0.00%)  2/384 (0.52%) 
Lower gastrointestinal haemorrhage  1  2/381 (0.52%)  0/384 (0.00%) 
Mallory-Weiss syndrome  1  1/381 (0.26%)  0/384 (0.00%) 
Nausea  1  4/381 (1.05%)  3/384 (0.78%) 
Pancreatitis  1  0/381 (0.00%)  1/384 (0.26%) 
Proctalgia  1  1/381 (0.26%)  0/384 (0.00%) 
Rectal haemorrhage  1  0/381 (0.00%)  1/384 (0.26%) 
Rectal obstruction  1  0/381 (0.00%)  1/384 (0.26%) 
Rectal tenesmus  1  0/381 (0.00%)  1/384 (0.26%) 
Small intestinal obstruction  1  0/381 (0.00%)  1/384 (0.26%) 
Subileus  1  1/381 (0.26%)  0/384 (0.00%) 
Vomiting  1  2/381 (0.52%)  5/384 (1.30%) 
General disorders     
Asthenia  1  3/381 (0.79%)  4/384 (1.04%) 
Chest pain  1  0/381 (0.00%)  1/384 (0.26%) 
Chills  1  1/381 (0.26%)  0/384 (0.00%) 
Condition aggravated  1  1/381 (0.26%)  0/384 (0.00%) 
Death  1  4/381 (1.05%)  2/384 (0.52%) 
Fatigue  1  1/381 (0.26%)  2/384 (0.52%) 
Gait disturbance  1  1/381 (0.26%)  0/384 (0.00%) 
General physical health deterioration  1  3/381 (0.79%)  0/384 (0.00%) 
Generalised oedema  1  1/381 (0.26%)  0/384 (0.00%) 
Malaise  1  0/381 (0.00%)  1/384 (0.26%) 
Oedema peripheral  1  0/381 (0.00%)  1/384 (0.26%) 
Pain  1  1/381 (0.26%)  3/384 (0.78%) 
Performance status decreased  1  3/381 (0.79%)  5/384 (1.30%) 
Pyrexia  1  4/381 (1.05%)  3/384 (0.78%) 
Systemic inflammatory response syndrome  1  0/381 (0.00%)  1/384 (0.26%) 
Thrombosis in device  1  1/381 (0.26%)  0/384 (0.00%) 
Hepatobiliary disorders     
Bile duct obstruction  1  0/381 (0.00%)  1/384 (0.26%) 
Bile duct stenosis  1  1/381 (0.26%)  0/384 (0.00%) 
Cholecystitis acute  1  0/381 (0.00%)  1/384 (0.26%) 
Drug-induced liver injury  1  1/381 (0.26%)  4/384 (1.04%) 
Hepatic failure  1  4/381 (1.05%)  2/384 (0.52%) 
Hepatic function abnormal  1  1/381 (0.26%)  1/384 (0.26%) 
Hyperbilirubinaemia  1  0/381 (0.00%)  2/384 (0.52%) 
Jaundice  1  0/381 (0.00%)  1/384 (0.26%) 
Jaundice cholestatic  1  1/381 (0.26%)  1/384 (0.26%) 
Liver disorder  1  0/381 (0.00%)  1/384 (0.26%) 
Immune system disorders     
Contrast media allergy  1  0/381 (0.00%)  1/384 (0.26%) 
Infections and infestations     
Bronchitis  1  0/381 (0.00%)  1/384 (0.26%) 
Cellulitis  1  1/381 (0.26%)  0/384 (0.00%) 
Device related infection  1  1/381 (0.26%)  0/384 (0.00%) 
Enterocolitis infectious  1  0/381 (0.00%)  1/384 (0.26%) 
Escherichia sepsis  1  1/381 (0.26%)  0/384 (0.00%) 
Influenza  1  0/381 (0.00%)  1/384 (0.26%) 
Liver abscess  1  0/381 (0.00%)  1/384 (0.26%) 
Lower respiratory tract infection  1  0/381 (0.00%)  1/384 (0.26%) 
Lung infection  1  0/381 (0.00%)  3/384 (0.78%) 
Oral candidiasis  1  0/381 (0.00%)  1/384 (0.26%) 
Peritonitis  1  0/381 (0.00%)  2/384 (0.52%) 
Pneumonia  1  5/381 (1.31%)  3/384 (0.78%) 
Postoperative wound infection  1  0/381 (0.00%)  1/384 (0.26%) 
Pyelonephritis  1  1/381 (0.26%)  0/384 (0.00%) 
Pyelonephritis acute  1  1/381 (0.26%)  0/384 (0.00%) 
Sepsis  1  0/381 (0.00%)  4/384 (1.04%) 
Septic shock  1  0/381 (0.00%)  1/384 (0.26%) 
Small intestine gangrene  1  0/381 (0.00%)  1/384 (0.26%) 
Streptococcal sepsis  1  0/381 (0.00%)  1/384 (0.26%) 
Upper respiratory tract infection  1  0/381 (0.00%)  1/384 (0.26%) 
Urinary tract infection  1  0/381 (0.00%)  6/384 (1.56%) 
Urinary tract infection pseudomonal  1  0/381 (0.00%)  1/384 (0.26%) 
Urosepsis  1  1/381 (0.26%)  0/384 (0.00%) 
Injury, poisoning and procedural complications     
Fall  1  0/381 (0.00%)  1/384 (0.26%) 
Hip fracture  1  1/381 (0.26%)  1/384 (0.26%) 
Spinal compression fracture  1  1/381 (0.26%)  0/384 (0.00%) 
Stoma site haemorrhage  1  0/381 (0.00%)  2/384 (0.52%) 
Investigations     
Alanine aminotransferase increased  1  3/381 (0.79%)  7/384 (1.82%) 
Aspartate aminotransferase increased  1  5/381 (1.31%)  6/384 (1.56%) 
Blood bilirubin increased  1  6/381 (1.57%)  2/384 (0.52%) 
Blood creatinine increased  1  2/381 (0.52%)  0/384 (0.00%) 
Hepatic enzyme increased  1  0/381 (0.00%)  2/384 (0.52%) 
Liver function test increased  1  0/381 (0.00%)  1/384 (0.26%) 
Weight decreased  1  0/381 (0.00%)  2/384 (0.52%) 
Metabolism and nutrition disorders     
Decreased appetite  1  5/381 (1.31%)  6/384 (1.56%) 
Dehydration  1  1/381 (0.26%)  4/384 (1.04%) 
Hyperkalaemia  1  3/381 (0.79%)  0/384 (0.00%) 
Hypoglycaemia  1  0/381 (0.00%)  1/384 (0.26%) 
Hyponatraemia  1  0/381 (0.00%)  1/384 (0.26%) 
Metabolic acidosis  1  0/381 (0.00%)  1/384 (0.26%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/381 (0.00%)  1/384 (0.26%) 
Back pain  1  5/381 (1.31%)  4/384 (1.04%) 
Fistula  1  0/381 (0.00%)  1/384 (0.26%) 
Flank pain  1  2/381 (0.52%)  0/384 (0.00%) 
Muscular weakness  1  0/381 (0.00%)  1/384 (0.26%) 
Musculoskeletal pain  1  3/381 (0.79%)  0/384 (0.00%) 
Spinal column stenosis  1  0/381 (0.00%)  1/384 (0.26%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bowen's disease  1  0/381 (0.00%)  1/384 (0.26%) 
Breast cancer  1  1/381 (0.26%)  0/384 (0.00%) 
Cancer pain  1  0/381 (0.00%)  1/384 (0.26%) 
Intracranial tumour haemorrhage  1  1/381 (0.26%)  0/384 (0.00%) 
Malignant ascites  1  1/381 (0.26%)  0/384 (0.00%) 
Malignant neoplasm progression  1  24/381 (6.30%)  27/384 (7.03%) 
Metastases to central nervous system  1  0/381 (0.00%)  1/384 (0.26%) 
Metastases to liver  1  1/381 (0.26%)  1/384 (0.26%) 
Metastases to spine  1  1/381 (0.26%)  0/384 (0.00%) 
Tumour associated fever  1  1/381 (0.26%)  0/384 (0.00%) 
Tumour haemorrhage  1  0/381 (0.00%)  1/384 (0.26%) 
Tumour pain  1  5/381 (1.31%)  1/384 (0.26%) 
Tumour perforation  1  1/381 (0.26%)  0/384 (0.00%) 
Nervous system disorders     
Altered state of consciousness  1  0/381 (0.00%)  1/384 (0.26%) 
Ataxia  1  0/381 (0.00%)  1/384 (0.26%) 
Brain oedema  1  3/381 (0.79%)  1/384 (0.26%) 
Cerebral haemorrhage  1  1/381 (0.26%)  0/384 (0.00%) 
Cerebral infarction  1  1/381 (0.26%)  0/384 (0.00%) 
Cognitive disorder  1  1/381 (0.26%)  0/384 (0.00%) 
Depressed level of consciousness  1  1/381 (0.26%)  0/384 (0.00%) 
Dizziness  1  0/381 (0.00%)  1/384 (0.26%) 
Dysarthria  1  0/381 (0.00%)  1/384 (0.26%) 
Haemorrhage intracranial  1  1/381 (0.26%)  0/384 (0.00%) 
Headache  1  2/381 (0.52%)  2/384 (0.52%) 
Hemiparesis  1  1/381 (0.26%)  1/384 (0.26%) 
Intracranial pressure increased  1  0/381 (0.00%)  1/384 (0.26%) 
Metabolic encephalopathy  1  1/381 (0.26%)  0/384 (0.00%) 
Nervous system disorder  1  1/381 (0.26%)  0/384 (0.00%) 
Paraesthesia  1  2/381 (0.52%)  2/384 (0.52%) 
Paraparesis  1  0/381 (0.00%)  1/384 (0.26%) 
Peroneal nerve palsy  1  0/381 (0.00%)  1/384 (0.26%) 
Seizure  1  1/381 (0.26%)  0/384 (0.00%) 
Sensory loss  1  0/381 (0.00%)  1/384 (0.26%) 
Spinal cord compression  1  1/381 (0.26%)  0/384 (0.00%) 
Syncope  1  0/381 (0.00%)  1/384 (0.26%) 
Psychiatric disorders     
Completed suicide  1  0/381 (0.00%)  1/384 (0.26%) 
Confusional state  1  1/381 (0.26%)  1/384 (0.26%) 
Delirium  1  0/381 (0.00%)  1/384 (0.26%) 
Renal and urinary disorders     
Acute kidney injury  1  3/381 (0.79%)  7/384 (1.82%) 
Focal segmental glomerulosclerosis  1  1/381 (0.26%)  0/384 (0.00%) 
Haematuria  1  1/381 (0.26%)  0/384 (0.00%) 
Hydronephrosis  1  5/381 (1.31%)  4/384 (1.04%) 
Micturition disorder  1  0/381 (0.00%)  1/384 (0.26%) 
Renal failure  1  1/381 (0.26%)  3/384 (0.78%) 
Renal impairment  1  0/381 (0.00%)  1/384 (0.26%) 
Urinary retention  1  1/381 (0.26%)  1/384 (0.26%) 
Reproductive system and breast disorders     
Pelvic pain  1  1/381 (0.26%)  0/384 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acquired diaphragmatic eventration  1  0/381 (0.00%)  1/384 (0.26%) 
Acute respiratory distress syndrome  1  1/381 (0.26%)  0/384 (0.00%) 
Aspiration  1  0/381 (0.00%)  1/384 (0.26%) 
Dyspnoea  1  12/381 (3.15%)  12/384 (3.13%) 
Haemoptysis  1  1/381 (0.26%)  0/384 (0.00%) 
Pleural effusion  1  6/381 (1.57%)  3/384 (0.78%) 
Pneumothorax  1  1/381 (0.26%)  0/384 (0.00%) 
Pulmonary embolism  1  2/381 (0.52%)  1/384 (0.26%) 
Respiratory distress  1  1/381 (0.26%)  0/384 (0.00%) 
Respiratory failure  1  0/381 (0.00%)  1/384 (0.26%) 
Vocal cord polyp  1  1/381 (0.26%)  0/384 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  2/381 (0.52%)  1/384 (0.26%) 
Hypertension  1  1/381 (0.26%)  0/384 (0.00%) 
Lymphoedema  1  1/381 (0.26%)  0/384 (0.00%) 
Vena cava thrombosis  1  1/381 (0.26%)  0/384 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Nintedanib
Affected / at Risk (%) Affected / at Risk (%)
Total   309/381 (81.10%)   351/384 (91.41%) 
Blood and lymphatic system disorders     
Anaemia  1  22/381 (5.77%)  23/384 (5.99%) 
Gastrointestinal disorders     
Abdominal pain  1  59/381 (15.49%)  65/384 (16.93%) 
Abdominal pain upper  1  21/381 (5.51%)  25/384 (6.51%) 
Constipation  1  57/381 (14.96%)  65/384 (16.93%) 
Diarrhoea  1  57/381 (14.96%)  175/384 (45.57%) 
Nausea  1  103/381 (27.03%)  163/384 (42.45%) 
Vomiting  1  71/381 (18.64%)  149/384 (38.80%) 
General disorders     
Asthenia  1  46/381 (12.07%)  54/384 (14.06%) 
Fatigue  1  89/381 (23.36%)  113/384 (29.43%) 
Oedema peripheral  1  28/381 (7.35%)  22/384 (5.73%) 
Pain  1  21/381 (5.51%)  9/384 (2.34%) 
Pyrexia  1  45/381 (11.81%)  53/384 (13.80%) 
Investigations     
Alanine aminotransferase increased  1  23/381 (6.04%)  90/384 (23.44%) 
Aspartate aminotransferase increased  1  44/381 (11.55%)  90/384 (23.44%) 
Blood alkaline phosphatase increased  1  22/381 (5.77%)  28/384 (7.29%) 
Blood bilirubin increased  1  15/381 (3.94%)  26/384 (6.77%) 
Weight decreased  1  13/381 (3.41%)  35/384 (9.11%) 
Metabolism and nutrition disorders     
Decreased appetite  1  96/381 (25.20%)  128/384 (33.33%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  6/381 (1.57%)  21/384 (5.47%) 
Back pain  1  30/381 (7.87%)  33/384 (8.59%) 
Nervous system disorders     
Headache  1  19/381 (4.99%)  25/384 (6.51%) 
Psychiatric disorders     
Insomnia  1  22/381 (5.77%)  30/384 (7.81%) 
Renal and urinary disorders     
Proteinuria  1  12/381 (3.15%)  34/384 (8.85%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  48/381 (12.60%)  42/384 (10.94%) 
Dyspnoea  1  40/381 (10.50%)  35/384 (9.11%) 
Skin and subcutaneous tissue disorders     
Rash  1  14/381 (3.67%)  20/384 (5.21%) 
Vascular disorders     
Hypertension  1  15/381 (3.94%)  42/384 (10.94%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02149108     History of Changes
Other Study ID Numbers: 1199.52
2012-000095-42 ( EudraCT Number: EudraCT )
First Submitted: May 26, 2014
First Posted: May 29, 2014
Results First Submitted: May 8, 2017
Results First Posted: July 21, 2017
Last Update Posted: July 21, 2017