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This active surveillance aims to collect the safety data of 100 NSCLC patients treated with nintedanib per the approved Indian label within 2 years from the date of commercial availability of the drug in India (23rd January 2017). The objective is to look at the safety of nintedanib in the real world setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Patients who started treatment with nintedanib & docetaxel after 23rd January, 2017 and have discontinued the drug at the time of participation in the active surveillance. | ||
| Group B | Patients who started treatment with nintedanib & docetaxel after 23rd January, 2017 and are continuing the drug at the time of participation in the active surveillance . | ||
| Group C | Patients who have been newly prescribed nintedanib & docetaxel at the time of participation in the active surveillance. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of All Adverse Drug Reactions (ADRs) in Nintedanib and Docetaxel Treated Patients | Incidence of all Adverse drug reactions (ADRs) in nintedanib and docetaxel treated patients. An Adverse Event (AE) was considered as an Adverse drug reaction (ADR) if either the physician who reported the AE or the sponsor assessed its causal relationship as 'related'. The incidence rate were calculated using number of patients with respective events divided by time at risk expressed as [100 pt -yrs]. | From first drug administration until 28 days after the last drug administration, up to 586 days. |
| Incidence Rate of All Serious Adverse Events (SAEs) in Nintedanib and Docetaxel Treated Patients | Incidence rate of all Serious Adverse Events (SAEs) in nintedanib and docetaxel treated patients. All Adverse Events (AEs) that occurred between the first intake of nintedanib plus docetaxel and within 28 days (inclusive) after the last intake were considered 'treatment emergent'. The incidence rate were calculated using number of patients with respective events divided by time at risk expressed as [100 pt -yrs]. | From first drug administration until 28 days after the last drug administration, up to 586 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Required Nintedanib Dose Reductions | Percentage of patients who required nintedanib dose reductions. | From first drug administration until 28 days after the last drug administration, up to 586 days. |
| Number of Patients Who Discontinued Study Drug Permanently Due to Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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This active surveillance aims to collect the safety data of 100 NSCLC patients treated with nintedanib per the approved Indian label within 2 years from the date of commercial availability of the drug in India (23rd January 2017).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zydus Hospitals and Healthcare Research Pvt. Ltd | Anand | 388001 | India | |||
| Narayana Hrudyalaya |
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| Label | URL |
|---|---|
| Related Info | View source |
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After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
The data shared are the raw clinical study data sets.
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
An active surveillance to monitor the real-world safety in Indian patients prescribed nintedanib as per approved Indian Label for the treatment of locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nintedanib and Docetaxel: Group A | Group A: Non-small cell lung cancer (NSCLC) patients who had started treatment with the approved Indian labels of nintedanib and docetaxel after 23rd January 2017 and had discontinued the drug at the time of participation in the active surveillance. |
| FG001 | Nintedanib and Docetaxel: Group B | Group B: Non-small cell lung cancer (NSCLC) patients who started treatment with the approved Indian labels of nintedanib and docetaxel after 23rd January 2017 and were continuing the drug at the time of participation in the active surveillance. |
| FG002 | Nintedanib and Docetaxel: Group C | Group C: Non-small cell lung cancer (NSCLC) patients were newly prescribed the approved Indian labels nintedanib and docetaxel at the time of participation in the active surveillance. |
| FG003 | Single Agent Docetaxel: Group I | Group I: Non-small cell lung cancer (NSCLC) patients who started treatment with docetaxel after 23rd January 2017 and had discontinued the drug at the time of participation in the active surveillance. Patients who received the single agent docetaxel were not followed up after the baseline visit as per the study design. |
| FG004 | Single Agent Docetaxel: Group II | Group II: Non-small cell lung cancer (NSCLC) patients who had started treatment with docetaxel after 23rd January 2017 and were continuing the drug at the time of participation in the active surveillance. Patients who received the single agent docetaxel were not followed up after the baseline visit as per the study design. |
| FG005 | Single Agent Docetaxel: Group III | Group III: Non-small cell lung cancer (NSCLC) patients who were newly prescribed docetaxel at the time of participation in the active surveillance. Patients who received the single agent docetaxel were not followed up after the baseline visit as per the study design. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Entered set (ES): Included patients who signed the Informed Consent Form (ICF) and met the eligibility criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | Nintedanib and Docetaxel: Group A | Group A: Non-small cell lung cancer (NSCLC) patients who had started treatment with the approved Indian labels of nintedanib and docetaxel after 23rd January 2017 and had discontinued the drug at the time of participation in the active surveillance. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of All Adverse Drug Reactions (ADRs) in Nintedanib and Docetaxel Treated Patients | Incidence of all Adverse drug reactions (ADRs) in nintedanib and docetaxel treated patients. An Adverse Event (AE) was considered as an Adverse drug reaction (ADR) if either the physician who reported the AE or the sponsor assessed its causal relationship as 'related'. The incidence rate were calculated using number of patients with respective events divided by time at risk expressed as [100 pt -yrs]. | Only patients who were treated with nintedanib and docetaxel and were included in the treated set (TS). TS: all patients who signed the informed consent form (ICF), met the eligibility criteria and had take at least one dose of study medication. Results are reported for overall nintedanib and doxetaxel group. According to the protcol, it was not planned to compare all 3 groups of nintedanib and docetaxel. | Posted | Number | 95% Confidence Interval | Patients per 100 patient years | From first drug administration until 28 days after the last drug administration, up to 586 days. |
|
From first drug administration until 28 days after the last drug administration, up to 586 days. All-cause mortality: Up to 51.5 months after first drug administration.
As defined in protocol safety data was not collected for patients treated with single agent docetaxel as they were not followed up after the baseline visit.
There was no plan to compare all 3 nintedanib and docetaxel groups according to the protocol.
Only patients who were treated with nintedanib and docetaxel and were included in the treated set (TS).
TS: all patients who signed the informed consent form (ICF), met the eligibility criteria and had take at least one dose of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Docetaxel and Nintedanib | Non-small cell lung cancer (NSCLC) patients who had started treatment with the approved Indian labels of nintedanib and docetaxel (all Groups). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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Study enrolled lower number of patients than the planned sample size due to low recruitment at the selected sites. The study was real-world active surveillance hence no examinations were mandated. Information collected as per clinical practice was available which may not have been consistent across patients and study duration.
The extent of retrospectively collected study data for patients in Group A and I were dependent on the information available in medical records at the time of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 4, 2021 | Sep 22, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 1, 2020 | Sep 22, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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Number of patients who discontinued study drug permanently due to adverse events. |
| From first drug administration until last drug administration, up to 558 days. |
| Bangalore |
| 560099 |
| India |
| Manipal Hospitals | Bengaluru | 560017 | India |
| HCG Hospital | Bengaluru | 560027 | India |
| Sparsh Hospitals and Critical Care | Bhubaneswar | 751007 | India |
| Action Cancer Hospital, Delhi | Delhi | 110063 | India |
| Apollo Health City Hospital | Hyderabad | 500033 | India |
| Yashoda Hospitals | Hyderabad | 500082 | India |
| Chittaranjan National Cancer Institute | Kolkata | 700026 | India |
| Rajiv Gandhi Cancer Institute and Research Centre | New Delhi | 110085 | India |
| SRM Institute of Medical Science | Vadapalani | 600026 | India |
| Progression of disease |
|
| Other than listed |
|
| Lost to Follow-up |
|
| Change to other anti-cancer therapy |
|
| Nintedanib and Docetaxel: Group B |
Group B: Non-small cell lung cancer (NSCLC) patients who started treatment with the approved Indian labels of nintedanib and docetaxel after 23rd January 2017 and were continuing the drug at the time of participation in the active surveillance. |
| BG002 | Nintedanib and Docetaxel: Group C | Group C: Non-small cell lung cancer (NSCLC) patients were newly prescribed the approved Indian labels nintedanib and docetaxel at the time of participation in the active surveillance. |
| BG003 | Single Agent Docetaxel: Group I | Group I: Non-small cell lung cancer (NSCLC) patients who started treatment with docetaxel after 23rd January 2017 and had discontinued the drug at the time of participation in the active surveillance. Patients who received the single agent docetaxel were not followed up after the baseline visit as per the study design. |
| BG004 | Single Agent Docetaxel: Group II | Group II: Non-small cell lung cancer (NSCLC) patients who had started treatment with docetaxel after 23rd January 2017 and were continuing the drug at the time of participation in the active surveillance. Patients who received the single agent docetaxel were not followed up after the baseline visit as per the study design. |
| BG005 | Single Agent Docetaxel: Group III | Group III: Non-small cell lung cancer (NSCLC) patients who were newly prescribed docetaxel at the time of participation in the active surveillance. Patients who received the single agent docetaxel were not followed up after the baseline visit as per the study design. |
| BG006 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG000 | Nintedanib and Docetaxel | Non-small cell lung cancer (NSCLC) patients who had started treatment with the approved Indian labels of nintedanib and docetaxel (all Groups). |
|
|
| Primary | Incidence Rate of All Serious Adverse Events (SAEs) in Nintedanib and Docetaxel Treated Patients | Incidence rate of all Serious Adverse Events (SAEs) in nintedanib and docetaxel treated patients. All Adverse Events (AEs) that occurred between the first intake of nintedanib plus docetaxel and within 28 days (inclusive) after the last intake were considered 'treatment emergent'. The incidence rate were calculated using number of patients with respective events divided by time at risk expressed as [100 pt -yrs]. | Only patients who were treated with nintedanib and docetaxel and were included in the treated set (TS). TS: all patients who signed the informed consent form (ICF), met the eligibility criteria and had take at least one dose of study medication. Results are reported for overall nintedanib and doxetaxel group. According to the protcol, it was not planned to compare all 3 groups of nintedanib and docetaxel. | Posted | Number | 95% Confidence Interval | Patients per 100 patient years | From first drug administration until 28 days after the last drug administration, up to 586 days. |
|
|
|
| Secondary | Percentage of Patients Who Required Nintedanib Dose Reductions | Percentage of patients who required nintedanib dose reductions. | Only patients who were treated with nintedanib and docetaxel and were included in the treated set (TS). TS: all patients who signed the informed consent form (ICF), met the eligibility criteria and had take at least one dose of study medication. Results are reported for overall nintedanib and doxetaxel group. According to the protcol, it was not planned to compare all 3 groups of nintedanib and docetaxel. | Posted | Number | Percentage of Participants | From first drug administration until 28 days after the last drug administration, up to 586 days. |
|
|
|
| Secondary | Number of Patients Who Discontinued Study Drug Permanently Due to Adverse Events | Number of patients who discontinued study drug permanently due to adverse events. | Only patients who were treated with nintedanib and docetaxel and were included in the treated set (TS). TS: all patients who signed the informed consent form (ICF), met the eligibility criteria and had take at least one dose of study medication. Results are reported for overall nintedanib and doxetaxel group. According to the protcol, it was not planned to compare all 3 groups of nintedanib and docetaxel. | Posted | Count of Participants | Participants | From first drug administration until last drug administration, up to 558 days. |
|
|
|
| 9 |
| 23 |
| 9 |
| 23 |
| 0 |
| 23 |
| Oedema peripheral | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Unresponsive to stimuli | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
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.
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Male |
|