A Study Evaluating the Efficacy and Tolerability of Velip... | NCT02412371 | Trialant
NCT02412371
Sponsor
AbbVie
Status
Terminated
Last Update Posted
Jul 22, 2020Actual
Enrollment
48Actual
Phase
Phase 1Phase 2
Conditions
Non-small Cell Lung Cancer Stage III
Interventions
Paclitaxel
Placebo for Veliparib
Carboplatin
Veliparib
Radiotherapy
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02412371
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M14-360
Secondary IDs
ID
Type
Description
Link
2016-001659-32
EudraCT Number
Brief Title
A Study Evaluating the Efficacy and Tolerability of Veliparib in Combination With Paclitaxel/Carboplatin-Based Chemoradiotherapy Followed by Veliparib and Paclitaxel/Carboplatin Consolidation in Adults With Stage III Non-Small Cell Lung Cancer (NSCLC)
Official Title
A Phase 1 Dose Escalation and Phase 2 Randomized, Placebo-Controlled Study of the Efficacy and Tolerability of Veliparib in Combination With Paclitaxel/Carboplatin-Based Chemoradiotherapy Followed by Veliparib and Paclitaxel/Carboplatin Consolidation in Subjects With Stage III Non-Small Cell Lung Cancer (NSCLC)
Acronym
Not provided
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
Jul 2020
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Phase 2 was not conducted due to a change in the standard of care for newly diagnosed, unresectable Stage III NSCLC
Expanded Access Info
No
Start Date
Apr 30, 2015Actual
Primary Completion Date
Aug 5, 2019Actual
Completion Date
Aug 5, 2019Actual
First Submitted Date
Nov 6, 2014
First Submission Date that Met QC Criteria
Apr 6, 2015
First Posted Date
Apr 9, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 9, 2020
Results First Submitted that Met QC Criteria
Jul 8, 2020
Results First Posted Date
Jul 22, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 8, 2020
Last Update Posted Date
Jul 22, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbVieINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study seeks to establish
the recommended Phase 2 dose (RPTD) of veliparib in combination with concurrent paclitaxel/carboplatin-based chemoradiotherapy (CRT) and consolidation with paclitaxel/carboplatin-based chemotherapy (Phase 1 portion), and
to assess whether the addition of oral veliparib versus placebo to paclitaxel/carboplatin-based chemoradiotherapy with paclitaxel/carboplatin consolidation will improve progression-free survival (PFS) in adults with Stage III non-small cell lung cancer (Phase 2 portion).
A strategy decision was made not to proceed to Phase 2 portion of this study due to change in standard of care.
Detailed Description
This was to be a 2-phase study consisting of
A Phase 1, dose escalation study of veliparib to determine a RPTD for combination with concurrent paclitaxel/carboplatin-based CRT and paclitaxel/carboplatin-based consolidation chemotherapy; followed by
A Phase 2, randomized, double-blinded study to determine whether veliparib improved outcome relative to placebo when added to paclitaxel/carboplatin based CRT followed by consolidation paclitaxel/carboplatin in adults with previously untreated Stage III NSCLC.
In the dose escalation phase (Phase 1) of the study participants will be assigned to ascending doses of veliparib in combination with carboplatin, paclitaxel, and thoracic radiotherapy for 7 weeks following a traditional "3 + 3" design. The first cohort of at least 3 - 6 participants will receive veliparib 60 mg twice a day (BID) throughout CRT. Dose limiting toxicity (DLT) events will be collected for each dosing cohort until a new dosing cohort is opened or until the RPTD is identified. Participants will also receive a consolidation dose of veliparib of 120 mg BID + carboplatin and paclitaxel for up to two 21-day cycles. Once the concurrent CRT RPTD is identified, an additional cohort will be enrolled to explore the tolerability of a consolidation dose of veliparib at 240 mg BID + carboplatin + paclitaxel for up to two 21-day cycles.
Following the dose escalation portion of the study, the RPTD will be determined by the sponsor and the Phase 2 portion of the study will begin with patient randomization in a 1:1:1 ratio to concurrent paclitaxel/carboplatin/radiotherapy/veliparib followed by consolidation paclitaxel/carboplatin/veliparib, concurrent paclitaxel/carboplatin/radiotherapy/veliparib followed by consolidation paclitaxel/carboplatin/placebo, or concurrent paclitaxel/carboplatin/radiotherapy/placebo followed by consolidation paclitaxel/carboplatin/placebo. Randomization will be stratified by tumor volume (≤ 90 versus > 90 cm³) and smoking history (current smoker versus former smoker versus never smoked).
Phase 2 was not carried out since during the study there was a change in standard of care for patients with newly diagnosed, unresectable Stage III NSCLC.
Participants in Phase 1 will be sequentially assigned to ascending dose levels of 60 mg, 80 mg, 120 mg, 200 mg, and 240 mg of twice daily (BID) veliparib in combination with carboplatin at an area under the concentration-time curve (AUC) 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent chemoradiotherapy participants will receive up to 2 cycles of consolidation therapy consisting of veliparib 120 mg or 240 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Participants will receive veliparib at the recommended phase 2 dose determined in Phase 1 in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent chemoradiotherapy participants will receive up to 2 cycles of consolidation therapy consisting of veliparib 120 mg or 240 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Participants will receive veliparib at the recommended phase 2 dose determined in Phase 1 in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent chemoradiotherapy participants will receive up to 2 cycles of consolidation therapy consisting of placebo to veliparib BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Paclitaxel
Drug
Administered via intravenous infusion on Day 1 of each treatment week (concurrent CRT) / cycle (consolidation)
Number of Participants With Dose-limiting Toxicities (DLTs)
DLTs were defined as the following events considered treatment-related by the Investigator, graded per Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Radiation-induced myelopathy/myelitis or ≥ Grade (G) 3 cardiac toxicity
Radiation-related pneumonitis resulting in delay in RT, CT, or veliparib of >3 weeks or early discontinuation (DC) of RT (total dose <50 Gy)
≥G4 esophagitis or esophagitis, dysphagia, and odynophagia requiring treatment interruption of >7 days despite medical management, neutropenia for >7 days or neutropenic fever or thrombocytopenia
≥G2 seizure
G4 diarrhea or nausea/vomiting despite antiemetic therapy for >48 hours
Any other toxicity resulting in delay in RT, CT or veliparib >14 days or early DC of RT
Other nonhematologic toxicities ≥G3, except anorexia, fatigue, G3 infection, G3 aspartate/alanine transferase (AST/ALT) elevations ≤7 days, infusion reactions, G3/4 lymphopenia or electrolyte abnormalities corrected to ≤G2 in <48 hours
For Cohorts 1 - 5, from the start of veliparib dosing through 28 days after RT completion or until initiation of consolidation CT, approx. 10 weeks; For Cohort 6, 21 days from start of consolidation CT or until the start of cycle 2 consolidation therapy.
Secondary Outcomes
Measure
Description
Time Frame
Objective Response Rate
Objective response rate (ORR) is defined as the percentage of participants who have a confirmed complete response (CR) or partial response (PR) as assessed by the investigator using RECIST v1.1. Participants who did not meet complete response or partial response, including those who did not have post-baseline radiological assessments were considered as non-responders.
Complete Response (CR): The disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Normalization of tumor marker level. All lymph nodes must be non-pathological in size (< 10 mm short axis).
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Response must have been confirmed 4 weeks after the first documentation.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants with histologically or cytologically confirmed Stage III non-small cell lung cancer (NSCLC).
Participants in the randomized portion of the study must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 criteria.
Participants must have V20 (volume of lung to receive 20 Gy radiotherapy according to simulation) < 35%.
Participant must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0 - 1.
Participant must have adequate hematologic, renal, hepatic, and lung function.
Participant must consent to provide archived tissue or cytology sample of NSCLC lesion for analysis.
Exclusion Criteria:
Participants with prior chemotherapy or radiotherapy (RT) for current NSCLC. Participants curatively treated for past early stage NSCLC greater than 3 years ago may be included.
Participants with prior exposure to poly-adenosine diphosphate (ADP)-ribose polymerase (PARP) inhibitors.
Participants with known hypersensitivity to carboplatin, paclitaxel, or formulations containing polyethoxylated castor oil (Cremophor).
Participants with prior mediastinal or thoracic radiotherapy. Prior tangential radiotherapy to prior breast cancer is acceptable.
Participants with major surgery in the 4 weeks prior to randomization (Video-assisted thoracoscopic surgery (VATS) and/or mediastinoscopy is not considered major surgery).
Participants with a previous or concurrent malignancy except for treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient received potentially curative treatment and has been disease-free for 3 years or is considered cured by the investigator if has been disease-free for less than 3 years.
Participant is pregnant or lactating.
Participant with sensory peripheral neuropathy of ≥ Grade 2 at baseline, unable to swallow medication, or participants with prior history of seizure within the prior 12 months.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
AbbVie Inc.
AbbVie
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Ucsd /Id# 133037
La Jolla
California
92093
United States
Christiana Care Health Service /ID# 133486
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Participants in Phase 1 were sequentially assigned to ascending dose levels of veliparib in combination with carboplatin/paclitaxel chemoradiotherapy. Phase 2 was not conducted since there was a change in standard of care for newly diagnosed, unresectable Stage III non-small cell lung cancer (NSCLC).
Results are reported for Phase 1.
Recruitment Details
This study enrolled 48 participants at 10 sites in the United States. The study was designed as a 2-phase study consisting of a Phase 1, dose escalation of veliparib in combination with concurrent chemoradiotherapy (CRT) and consolidation chemotherapy (CT) and a Phase 2, randomized, double-blinded study.
Participants received 60 mg veliparib twice daily (BID) in combination with carboplatin at an area under the concentration-time curve (AUC) 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy (RT) for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Aug 15, 2017
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Czechia
Greece
Spain
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
In the dose escalation phase (Phase 1) of the study participants will be enrolled sequentially to receive ascending dose of veliparib in combination with carboplatin + paclitaxel + thoracic radiotherapy.
In the Phase 2 portion of the study participants were to be randomized in a 1:1:1 ratio to one of three treatment arms.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
All participants will be treated with open-label paclitaxel and carboplatin (Phase 1 and Phase 2).
Participants in Phase 1 will be treated with open-label veliparib. In Phase 2, the Sponsor, Investigator, study site personnel and participant were to be be blinded to each participant's treatment with veliparib or placebo throughout the course of the study.
Participants will receive placebo to veliparib with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent chemoradiotherapy participants will receive up to 2 cycles of consolidation therapy consisting of placebo to veliparib BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Tumor assessments were performed prior to consolidation chemotherapy, 24 weeks after start of treatment, every 8 weeks until 1 year after start of treatment, and then every 12 weeks until disease progression; median time on follow-up was 11 months.
Newark
Delaware
19713
United States
University of Chicago /ID# 133828
Chicago
Illinois
60637-1443
United States
Univ Maryland School Medicine /ID# 132944
Baltimore
Maryland
21201
United States
Dana-Farber Cancer Institute /ID# 133494
Boston
Massachusetts
02215
United States
SUNY Upstate Medical University - Downtown /ID# 133492
Participants received 80 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Participants received 120 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Participants received 200 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 240 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
FG0007 subjects
FG0019 subjects
FG0027 subjects
FG0038 subjects
FG00412 subjects
FG0055 subjects
COMPLETED
Completed indicates participants remaining on study.
Participants received 60 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Participants received 80 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Participants received 120 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Participants received 200 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 240 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0007
BG0019
BG0027
BG0038
BG00412
BG0055
BG00648
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00069.1± 6.39
BG00165.7± 7.55
BG00266.9± 9.84
BG003
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
40 - < 60 years
BG0000
BG0011
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0016
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG0006
BG0019
BG002
Eastern Cooperative Oncology Group (ECOG) Performance Score
ECOG performance status is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis.
0 = Fully Active (Most Favorable Activity);
1 = Restricted activity but ambulatory;
2 = Ambulatory but unable to carry out work activities;
3 = Limited Self-Care;
4 = Completely Disabled, No self-care (Least Favorable Activity)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Grade 0 (Fully active)
BG0003
BG001
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
Number of Participants With Dose-limiting Toxicities (DLTs)
DLTs were defined as the following events considered treatment-related by the Investigator, graded per Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Radiation-induced myelopathy/myelitis or ≥ Grade (G) 3 cardiac toxicity
Radiation-related pneumonitis resulting in delay in RT, CT, or veliparib of >3 weeks or early discontinuation (DC) of RT (total dose <50 Gy)
≥G4 esophagitis or esophagitis, dysphagia, and odynophagia requiring treatment interruption of >7 days despite medical management, neutropenia for >7 days or neutropenic fever or thrombocytopenia
≥G2 seizure
G4 diarrhea or nausea/vomiting despite antiemetic therapy for >48 hours
Any other toxicity resulting in delay in RT, CT or veliparib >14 days or early DC of RT
Other nonhematologic toxicities ≥G3, except anorexia, fatigue, G3 infection, G3 aspartate/alanine transferase (AST/ALT) elevations ≤7 days, infusion reactions, G3/4 lymphopenia or electrolyte abnormalities corrected to ≤G2 in <48 hours
Participants who received at least 1 dose of veliparib
Posted
Count of Participants
Participants
For Cohorts 1 - 5, from the start of veliparib dosing through 28 days after RT completion or until initiation of consolidation CT, approx. 10 weeks; For Cohort 6, 21 days from start of consolidation CT or until the start of cycle 2 consolidation therapy.
Participants received 60 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Participants received 80 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Participants received 120 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Participants received 200 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0007
OG0019
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Objective Response Rate
Objective response rate (ORR) is defined as the percentage of participants who have a confirmed complete response (CR) or partial response (PR) as assessed by the investigator using RECIST v1.1. Participants who did not meet complete response or partial response, including those who did not have post-baseline radiological assessments were considered as non-responders.
Complete Response (CR): The disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Normalization of tumor marker level. All lymph nodes must be non-pathological in size (< 10 mm short axis).
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Response must have been confirmed 4 weeks after the first documentation.
Participants who received at least 1 dose of veliparib and with at least one post-baseline tumor assessment
Posted
Number
95% Confidence Interval
percentage of participants
Tumor assessments were performed prior to consolidation chemotherapy, 24 weeks after start of treatment, every 8 weeks until 1 year after start of treatment, and then every 12 weeks until disease progression; median time on follow-up was 11 months.
Participants received 60 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Post-Hoc
Progression-free Survival
Progression-free survival (PFS) was defined as the time from first dose of study drug to the date of earliest radiographic disease progression per investigator assessment based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death, and was calculated using Kaplan-Meier methods. All radiographic disease progression was included regardless whether the event occurred while the participant was taking study drug or had previously discontinued study drug. Participants who did not experience radiographic disease progression or death were censored at the date of the last disease assessment. Participants with no post-baseline disease assessment were censored at first dose date plus 1 day.
Progressive disease (PD) was defined as at least a 20% increase in the size of target lesions with an absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.
All participants who received veliparib; PFS was pre-specified in the Protocol as a primary endpoint in Phase 2, which was not conducted. For Phase 1 PFS was not a pre-specified endpoint, and was only analyzed for all treatment cohorts combined due to the small sample sizes within each cohort.
Posted
Median
95% Confidence Interval
months
From first dose until end of study; maximum time on follow-up was approximately 46 months.
ID
Title
Description
OG000
Total
Participants received veliparib twice daily (BID) in combination with carboplatin at an area under the concentration-time curve (AUC) 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 or 240 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Post-Hoc
Overall Survival
Overall survival (OS) was defined as the time from the participant's first dose of study drug to the date of death, and was calculated using Kaplan-Meier methods. Participants who did not die were censored at the date of last study visit or the last known date to be alive, whichever was later.
All participants who received veliparib; OS was pre-specified in the Protocol as a secondary endpoint in Phase 2, which was not conducted. For Phase 1 OS was not a pre-specified endpoint, and was only analyzed for all treatment cohorts combined due to the small sample sizes within each cohort.
Posted
Median
95% Confidence Interval
months
From first dose of study drug until end of study; maximum time on follow-up was approximately 46 months.
ID
Title
Description
OG000
Total
Participants received veliparib twice daily (BID) in combination with carboplatin at an area under the concentration-time curve (AUC) 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 or 240 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Units
Counts
Participants
Post-Hoc
Duration of Overall Response (DOR)
Duration of overall response was defined as time from the date of first response (CR or PR) to the earliest documentation of radiographic progressive disease or death due to disease progression, calculated using Kaplan-Meier methods. Participants who did not experience radiographic disease progression or death were censored at the date of the last disease assessment.
Participants who received at least 1 dose of veliparib with at least 1 post-baseline tumor assessment and a confirmed response; DOR was prespecified as a secondary endpoint in Phase 2, which was not conducted. For Phase 1 DOR was not a prespecified endpoint and was only analyzed for all cohorts combined due to the small sample size of each cohort.
Posted
Median
95% Confidence Interval
months
Tumor assessments were performed prior to consolidation chemotherapy, 24 weeks after start of treatment, every 8 weeks until 1 year after start of treatment, and then every 12 weeks until disease progression; median time on follow-up was 11 months.
ID
Title
Description
OG000
Total
Participants received veliparib twice daily (BID) in combination with carboplatin at an area under the concentration-time curve (AUC) 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 or 240 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Time Frame
Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
Participants received 60 mg veliparib BID in combination with carboplatin at an area under the concentration-time curve (AUC) 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Participants received 80 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Participants received 120 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Participants received 200 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 240 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
3
5
2
5
5
5
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
FEBRILE NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected12 at risk
EG0053 events1 affected5 at risk
CARDIAC ARREST
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
CARDIAC TAMPONADE
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected7 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected7 at risk
EG003
OESOPHAGEAL OBSTRUCTION
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected7 at risk
EG003
OESOPHAGEAL STENOSIS
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected7 at risk
EG003
OESOPHAGITIS
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected7 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
NON-CARDIAC CHEST PAIN
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
PYREXIA
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected7 at risk
EG003
SEPSIS
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
RADIATION PNEUMONITIS
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0012 events2 affected9 at risk
EG0020 events0 affected7 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
HAEMOPTYSIS
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected7 at risk
EG003
PNEUMONIA ASPIRATION
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
PULMONARY OEDEMA
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0009 events3 affected7 at risk
EG0014 events3 affected9 at risk
EG0026 events3 affected7 at risk
EG0033 events1 affected8 at risk
EG00411 events6 affected12 at risk
EG00510 events3 affected5 at risk
FEBRILE NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected7 at risk
EG003
LEUKOCYTOSIS
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
LEUKOPENIA
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0003 events3 affected7 at risk
EG0017 events4 affected9 at risk
EG00212 events3 affected7 at risk
EG003
LYMPHOPENIA
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0003 events1 affected7 at risk
EG0015 events2 affected9 at risk
EG0021 events1 affected7 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0004 events3 affected7 at risk
EG0017 events6 affected9 at risk
EG00212 events6 affected7 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0018 events6 affected9 at risk
EG0027 events3 affected7 at risk
EG003
ANGINA PECTORIS
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
ATRIAL FIBRILLATION
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
PALPITATIONS
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
SINUS TACHYCARDIA
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
TACHYCARDIA
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0022 events1 affected7 at risk
EG003
VENTRICULAR TACHYCARDIA
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected7 at risk
EG003
EXTERNAL EAR PAIN
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected7 at risk
EG003
TINNITUS
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
DRY EYE
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected7 at risk
EG003
VISION BLURRED
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected7 at risk
EG003
VITREOUS FLOATERS
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
ABDOMINAL DISTENSION
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected7 at risk
EG003
ABDOMINAL PAIN LOWER
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0005 events4 affected7 at risk
EG0012 events2 affected9 at risk
EG0023 events2 affected7 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0004 events4 affected7 at risk
EG0012 events2 affected9 at risk
EG0024 events2 affected7 at risk
EG003
DRY MOUTH
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected7 at risk
EG003
DYSPHAGIA
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0007 events5 affected7 at risk
EG0011 events1 affected9 at risk
EG0024 events4 affected7 at risk
EG003
FLATULENCE
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected7 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected9 at risk
EG0022 events1 affected7 at risk
EG003
GINGIVAL BLEEDING
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected7 at risk
EG003
HAEMORRHOIDS
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0004 events3 affected7 at risk
EG0018 events5 affected9 at risk
EG00210 events5 affected7 at risk
EG003
ODYNOPHAGIA
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected7 at risk
EG003
OESOPHAGEAL PAIN
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
OESOPHAGEAL STENOSIS
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
OESOPHAGEAL ULCER
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected7 at risk
EG003
OESOPHAGITIS
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0004 events4 affected7 at risk
EG0017 events6 affected9 at risk
EG0027 events4 affected7 at risk
EG003
ORAL PAIN
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
STOMATITIS
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0016 events4 affected9 at risk
EG0023 events2 affected7 at risk
EG003
ASTHENIA
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected7 at risk
EG003
CATHETER SITE PAIN
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
CHEST PAIN
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected9 at risk
EG0022 events1 affected7 at risk
EG003
CHILLS
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
EXTRAVASATION
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected7 at risk
EG003
FATIGUE
General disorders
MedDRA 22.0
Systematic Assessment
EG0009 events6 affected7 at risk
EG0016 events6 affected9 at risk
EG0028 events5 affected7 at risk
EG003
FEELING HOT
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
GRAVITATIONAL OEDEMA
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
INJECTION SITE REACTION
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
LOCALISED OEDEMA
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
MALAISE
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected7 at risk
EG003
MEDICAL DEVICE SITE ERYTHEMA
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
MUCOSAL DRYNESS
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected7 at risk
EG003
MUCOSAL INFLAMMATION
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected7 at risk
EG003
NON-CARDIAC CHEST PAIN
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected7 at risk
EG003
PERFORMANCE STATUS DECREASED
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected7 at risk
EG003
PERIPHERAL SWELLING
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected7 at risk
EG003
PYREXIA
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0023 events1 affected7 at risk
EG003
SWELLING FACE
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
DRUG HYPERSENSITIVITY
Immune system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected7 at risk
EG003
BACTERAEMIA
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected7 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0013 events3 affected9 at risk
EG0020 events0 affected7 at risk
EG003
CANDIDA INFECTION
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
CATHETER SITE CELLULITIS
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
CATHETER SITE INFECTION
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
DIARRHOEA INFECTIOUS
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
FUNGAL INFECTION
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
HERPES SIMPLEX OESOPHAGITIS
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
HERPES ZOSTER
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
LARYNGITIS
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected7 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
OESOPHAGEAL CANDIDIASIS
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
ORAL CANDIDIASIS
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected7 at risk
EG003
OTITIS EXTERNA
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected7 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected7 at risk
EG003
VULVOVAGINAL CANDIDIASIS
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
INCISION SITE COMPLICATION
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
INFUSION RELATED REACTION
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected7 at risk
EG003
MUSCLE STRAIN
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
RADIATION INJURY
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
RADIATION OESOPHAGITIS
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected7 at risk
EG003
RADIATION PNEUMONITIS
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
RADIATION SKIN INJURY
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0004 events2 affected7 at risk
EG0012 events2 affected9 at risk
EG0020 events0 affected7 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected7 at risk
EG003
BLOOD ALKALINE PHOSPHATASE INCREASED
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
BLOOD BILIRUBIN INCREASED
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected7 at risk
EG003
BLOOD CREATININE INCREASED
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected7 at risk
EG003
BLOOD GLUCOSE INCREASED
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0022 events1 affected7 at risk
EG003
BLOOD PRESSURE INCREASED
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
ELECTROCARDIOGRAM QT PROLONGED
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0023 events1 affected7 at risk
EG003
WEIGHT DECREASED
Investigations
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0013 events2 affected9 at risk
EG0024 events3 affected7 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0003 events3 affected7 at risk
EG0015 events5 affected9 at risk
EG0023 events3 affected7 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0012 events2 affected9 at risk
EG0025 events4 affected7 at risk
EG003
HYPERGLYCAEMIA
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0013 events3 affected9 at risk
EG0022 events1 affected7 at risk
EG003
HYPERKALAEMIA
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected7 at risk
EG003
HYPERLIPIDAEMIA
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
HYPERMAGNESAEMIA
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
HYPERTRIGLYCERIDAEMIA
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
HYPOALBUMINAEMIA
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected7 at risk
EG003
HYPOCALCAEMIA
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected9 at risk
EG0023 events1 affected7 at risk
EG003
HYPOMAGNESAEMIA
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0011 events1 affected9 at risk
EG0022 events1 affected7 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0012 events2 affected9 at risk
EG0021 events1 affected7 at risk
EG003
HYPOPHAGIA
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
LACTIC ACIDOSIS
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected7 at risk
EG003
ARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
BONE PAIN
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected7 at risk
EG003
COSTOCHONDRITIS
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected7 at risk
EG003
FLANK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
JOINT SWELLING
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected7 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0022 events1 affected7 at risk
EG003
MUSCULAR WEAKNESS
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected7 at risk
EG003
MUSCULOSKELETAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected7 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected7 at risk
EG003
NECK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0012 events2 affected9 at risk
EG0020 events0 affected7 at risk
EG003
TENDONITIS
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
BENIGN BREAST NEOPLASM
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected7 at risk
EG003
TUMOUR PAIN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected7 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected9 at risk
EG0022 events2 affected7 at risk
EG003
DIZZINESS POSTURAL
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
DYSGEUSIA
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected7 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0013 events2 affected9 at risk
EG0026 events3 affected7 at risk
EG003
NEURALGIA
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
PARAESTHESIA
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
PERIPHERAL MOTOR NEUROPATHY
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
PERIPHERAL SENSORY NEUROPATHY
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0004 events2 affected7 at risk
EG0011 events1 affected9 at risk
EG0023 events2 affected7 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
TASTE DISORDER
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected7 at risk
EG003
TREMOR
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected7 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0002 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected7 at risk
EG003
NERVOUSNESS
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
ACUTE KIDNEY INJURY
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected7 at risk
EG003
HAEMATURIA
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
PROTEINURIA
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
URINARY TRACT PAIN
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
VULVOVAGINAL RASH
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0005 events5 affected7 at risk
EG0013 events3 affected9 at risk
EG0021 events1 affected7 at risk
EG003
DYSPHONIA
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected7 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0011 events1 affected9 at risk
EG0022 events2 affected7 at risk
EG003
DYSPNOEA EXERTIONAL
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
EPISTAXIS
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected7 at risk
EG003
HAEMOPTYSIS
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
HYPOXIA
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected7 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected7 at risk
EG003
PARANASAL SINUS HYPERSECRETION
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
PNEUMOTHORAX
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected7 at risk
EG003
PRODUCTIVE COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected7 at risk
EG003
PULMONARY EMBOLISM
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected7 at risk
EG003
RHINORRHOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected7 at risk
EG003
SINUS CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
THROAT IRRITATION
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected7 at risk
EG003
WHEEZING
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected7 at risk
EG003
ALOPECIA
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0011 events1 affected9 at risk
EG0022 events2 affected7 at risk
EG003
DERMATITIS
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected9 at risk
EG0023 events1 affected7 at risk
EG003
DRY SKIN
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
ECCHYMOSIS
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
ERYTHEMA
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected7 at risk
EG003
HYPERHIDROSIS
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
PAIN OF SKIN
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0005 events2 affected7 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected7 at risk
EG003
RASH ERYTHEMATOUS
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected9 at risk
EG0022 events1 affected7 at risk
EG003
RASH MACULO-PAPULAR
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
RASH PAPULAR
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected7 at risk
EG003
RASH PRURITIC
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
SKIN DISCOLOURATION
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
SKIN EXFOLIATION
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
SKIN HYPERPIGMENTATION
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected7 at risk
EG003
HOT FLUSH
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected7 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0011 events1 affected9 at risk
EG0022 events1 affected7 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 240 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Participants received 80 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Participants received 120 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Participants received 200 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 240 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0006
OG0018
OG0027
OG0038
OG00411
OG0053
Title
Denominators
Categories
Title
Measurements
OG00050.0(11.8 to 88.2)
OG00150.0(15.7 to 84.3)
OG002100.0(59.0 to 100)
OG00362.5(24.5 to 91.5)
OG00472.7(39.0 to 94.0)
OG0050.0(0.0 to 70.8)
Units
Counts
Participants
OG00048
Title
Denominators
Categories
Title
Measurements
OG00019.6(9.7 to 32.6)
OG00048
Title
Denominators
Categories
Title
Measurements
OG00032.6(15.0 to NA)Could not be calculated due to the low number of events
Units
Counts
Participants
OG00027
Title
Denominators
Categories
Title
Measurements
OG00030.4(17.5 to NA)Could not be estimated due to the low number of events