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Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Adults Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers

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ClinicalTrials.gov Identifier: NCT02264990
Recruitment Status : Completed
First Posted : October 15, 2014
Results First Posted : February 26, 2021
Last Update Posted : February 26, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-squamous Non-small Cell Lung Cancer
Interventions Drug: Paclitaxel
Drug: Carboplatin
Drug: Cisplatin
Drug: Veliparib
Drug: Pemetrexed
Enrollment 595
Recruitment Details Participants were enrolled at 131 sites in 20 countries (Argentina, Australia, Canada, Czech Republic, Denmark, Finland, Germany, Hungary, Israel, Japan, South Korea, Netherlands, New Zealand, Russian Federation, South Africa, Spain, Taiwan, Turkey, United Kingdom, and United States).
Pre-assignment Details Participants were randomized in a 1:1 ratio to veliparib in combination with carboplatin and paclitaxel (C/P) or investigator's choice of platinum doublet chemotherapy. Randomization was stratified by smoking status (current versus former), by the investigators' preferred platinum doublet therapy (carboplatin/paclitaxel versus cisplatin/pemetrexed versus carboplatin/pemetrexed), by gender (male versus female) and by Eastern Cooperative Oncology Group (ECOG) performance status (0 versus 1).
Arm/Group Title Investigator's Choice Chemotherapy Veliparib + Carboplatin + Paclitaxel
Hide Arm/Group Description

Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:

  • Carboplatin at an area under the curve (AUC) of 6 mg/mL*min + paclitaxel 200 mg/m²
  • Cisplatin 75 mg/m² + pemetrexed 500 mg/m²
  • Carboplatin AUC 6 or AUC 5 mg/mL*min + pemetrexed 500 mg/m²

After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.

Participants received 120 mg veliparib twice a day (BID) on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.

After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
Period Title: Overall Study
Started 297 298
Received Treatment 288 293
Received Maintenance Therapy 148 123
Completed 37 39
Not Completed 260 259
Reason Not Completed
Death             255             250
Withdrawal by Subject             4             5
Lost to Follow-up             1             3
Other             0             1
Arm/Group Title Investigator's Choice Chemotherapy Veliparib + Carboplatin + Paclitaxel Total
Hide Arm/Group Description

Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:

  • Carboplatin AUC 6 mg/mL*min + paclitaxel 200 mg/m²
  • Cisplatin 75 mg/m² + pemetrexed 500 mg/m²
  • Carboplatin AUC 6 or AUC 5 mg/mL*min + pemetrexed 500 mg/m²

After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.

Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.

After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.

 Total of all reporting groups
Overall Number of Baseline Participants 297 298 595
Hide Baseline Analysis Population Description
The intention-to-treat (ITT) population included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 297 participants 298 participants 595 participants
63.1  (8.99) 62.7  (9.02) 62.9  (9.0)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 297 participants 298 participants 595 participants
< 65 years
153
  51.5%
163
  54.7%
316
  53.1%
≥ 65 years
144
  48.5%
135
  45.3%
279
  46.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 297 participants 298 participants 595 participants
Female
90
  30.3%
92
  30.9%
182
  30.6%
Male
207
  69.7%
206
  69.1%
413
  69.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 297 participants 298 participants 595 participants
Hispanic or Latino
22
   7.4%
26
   8.7%
48
   8.1%
Not Hispanic or Latino
275
  92.6%
272
  91.3%
547
  91.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 297 participants 298 participants 595 participants
White
233
  78.5%
229
  76.8%
462
  77.6%
Black
11
   3.7%
11
   3.7%
22
   3.7%
Asian
53
  17.8%
57
  19.1%
110
  18.5%
Other
0
   0.0%
1
   0.3%
1
   0.2%
Region  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 297 participants 298 participants 595 participants
US and Western Europe and Australia and Canada
177
  59.6%
157
  52.7%
334
  56.1%
Eastern Europe/Russia
68
  22.9%
88
  29.5%
156
  26.2%
Japan
37
  12.5%
35
  11.7%
72
  12.1%
Other Asian
15
   5.1%
18
   6.0%
33
   5.5%
Smoking Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 297 participants 298 participants 595 participants
Current smoker
153
  51.5%
152
  51.0%
305
  51.3%
Past smoker
144
  48.5%
146
  49.0%
290
  48.7%
Investigators' Preferred Platinum Doublet Therapy   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 297 participants 298 participants 595 participants
Carboplatin/paclitaxel
71
  23.9%
70
  23.5%
141
  23.7%
Cisplatin/pemetrexed
95
  32.0%
100
  33.6%
195
  32.8%
Carboplatin/pemetrexed
131
  44.1%
128
  43.0%
259
  43.5%
[1]
Measure Description: The investigator's preferred choice of platinum doublet therapy, prior to randomization, which was used as a stratification factor. Note that while the investigator's pre-randomization preferred choice for the doublet is summarized, all participants on the veliparib arm received carboplatin and paclitaxel as chemotherapy.
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 297 participants 298 participants 595 participants
Grade 0 (fully active)
113
  38.0%
116
  38.9%
229
  38.5%
Grade 1 (restricted but ambulatory)
184
  62.0%
182
  61.1%
366
  61.5%
[1]
Measure Description:

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;
  • 1 = Restricted activity but ambulatory;
  • 2 = Ambulatory but unable to carry out work activities;
  • 3 = Limited Self-Care;
  • 4 = Completely Disabled, No self-care
Lung Subtype Panel (LSP) Assay Results   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants 114 participants 207 participants
LSP positive
40
  43.0%
40
  35.1%
80
  38.6%
LSP negative
53
  57.0%
74
  64.9%
127
  61.4%
[1]
Measure Description:

LSP positive: Patients with tumors classified as positive for the gene expression-based lung subtype panel (LSP) biomarker

LSP negative: Patients with tumors classified as negative for the gene expression-based lung subtype panel (LSP) biomarker

[2]
Measure Analysis Population Description: Participants with a tumor tissue sample available with sufficient tumor content for LSP status evaluation, and with an analytically valid LSP result.
1.Primary Outcome
Title Overall Survival (OS) in the Lung Subtype Panel Positive Subgroup
Hide Description Overall survival is defined as the time from the date that the participant was randomized to the date of the participant's death. Overall survival was estimated using Kaplan-Meier methodology. Participants still alive at the data cut-off date were censored at the date they were last known to be alive.
Time Frame From randomization up to the data cut-off date of 15 July 2019; median follow-up time was 44.5 and 45.3 months in LSP+ participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT population who were LSP positive (LSP+)
Arm/Group Title Investigator's Choice Chemotherapy Veliparib + Carboplatin + Paclitaxel
Hide Arm/Group Description:

Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:

  • Carboplatin AUC 6 mg/mL*min + paclitaxel 200 mg/m²
  • Cisplatin 75 mg/m² + pemetrexed 500 mg/m²
  • Carboplatin AUC 6 or AUC 5 mg/mL*min + pemetrexed 500 mg/m²

After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.

Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.

After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
Overall Number of Participants Analyzed 40 40
Median (95% Confidence Interval)
Unit of Measure: months
9.2
(5.1 to 11.7)
11.2
(7.5 to 15.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigator's Choice Chemotherapy, Veliparib + Carboplatin + Paclitaxel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments A fixed sequence testing procedure was used for analyses of the primary and secondary efficacy endpoints to control for the familywise error rate. If veliparib plus C/P treatment was not statistically significantly better compared to the investigators' choice of standard therapy for the primary efficacy endpoint of OS in LSP+ participants, then statistical significance would not be declared for any of the secondary efficacy endpoints.
Statistical Test of Hypothesis P-Value 0.113
Comments Statistical significance was determined by a two-sided P value ≤ 0.05.
Method Log Rank
Comments Log rank test stratified by ECOG performance status, investigators' preferred platinum therapy, and gender.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.644
Confidence Interval (2-Sided) 95%
0.396 to 1.048
Estimation Comments Hazard ratio obtained using the covariate adjusted Cox Proportional Hazard Model with covariates being ECOG performance status, investigators' preferred platinum therapy, and gender.
2.Secondary Outcome
Title Progression Free Survival (PFS) in the Lung Subtype Panel Positive Subgroup
Hide Description

Progression-free survival is defined as the time from the date of randomization to the date of disease progression (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death (all causes of mortality), whichever occurred first.

PD: At least a 20% increase in the size of target lesions, taking as reference the smallest size recorded since the treatment started (Baseline or after) with an absolute increase of at least 5 mm, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.

PFS was estimated using Kaplan-Meier methodology. Participants who did not have an event of disease progression or had not died on or before the cutoff date were censored at the date of their last disease progression assessment on or before the cut-off date. Any PD and death occurring > 26 weeks and > 12 weeks after the previous assessment, respectively, were excluded and patients were censored at last assessment before PD or death.
Time Frame From randomization up to the data cut-off date of 15 July 2019; the median follow-up time was 44.5 and 45.3 months in LSP+ participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT population who were LSP positive
Arm/Group Title Investigator's Choice Chemotherapy Veliparib + Carboplatin + Paclitaxel
Hide Arm/Group Description:

Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:

  • Carboplatin AUC 6 mg/mL*min + paclitaxel 200 mg/m²
  • Cisplatin 75 mg/m² + pemetrexed 500 mg/m²
  • Carboplatin AUC 6 or AUC 5 mg/mL*min + pemetrexed 500 mg/m²

After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.

Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.

After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
Overall Number of Participants Analyzed 40 40
Median (95% Confidence Interval)
Unit of Measure: months
5.2
(2.8 to 6.2)
6.3
(3.5 to 7.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigator's Choice Chemotherapy, Veliparib + Carboplatin + Paclitaxel
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.260
Comments [Not Specified]
Method Log Rank
Comments Log-rank test stratified by investigator's preferred platinum therapy, gender, and ECOG performance status.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.647
Confidence Interval (2-Sided) 95%
0.388 to 1.080
Estimation Comments The hazard ratio was obtained using the covariate adjusted Cox Proportional Hazard Model with covariates of ECOG performance status, investigators' preferred platinum therapy, and gender.
3.Secondary Outcome
Title Objective Response Rate (ORR) in the Lung Subtype Panel Positive Subgroup
Hide Description

Objective response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria. Response must have been confirmed at a consecutive assessment 28 days or more after the assessment at which response was first observed.

CR: The disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters, persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, or any new lesions.
Time Frame Assessed on Day 1 of Cycles 3 and 5 then every 9 weeks for 1 year or until maintenance therapy was discontinued, then every 12 weeks until radiographic progression or death; median time on follow-up was 5.2 and 6.3 months in each group, respectively.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT population who were LSP positive
Arm/Group Title Investigator's Choice Chemotherapy Veliparib + Carboplatin + Paclitaxel
Hide Arm/Group Description:

Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:

  • Carboplatin AUC 6 mg/mL*min + paclitaxel 200 mg/m²
  • Cisplatin 75 mg/m² + pemetrexed 500 mg/m²
  • Carboplatin AUC 6 or AUC 5 mg/mL*min + pemetrexed 500 mg/m²

After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.

Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.

After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
30.0
(16.6 to 46.5)
22.5
(10.8 to 38.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigator's Choice Chemotherapy, Veliparib + Carboplatin + Paclitaxel
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.455
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression adjusted for the covariates of ECOG performance status, investigators' preferred platinum therapy, and gender.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.66
Confidence Interval (2-Sided) 95%
0.23 to 1.90
Estimation Comments Odds ratio is from covariate adjusted logistic regression with the covariates being ECOG performance status, investigators' preferred platinum therapy, and gender.
4.Secondary Outcome
Title Overall Survival in All Participants
Hide Description Overall survival is defined as the time from the date that the participant was randomized to the date of the participant's death. OS was estimated using Kaplan-Meier methodology. Participants still alive at the data cut-off date were censored at the date they were last known to be alive.
Time Frame From randomization up to the data cut-off date of 15 July 2019; the median OS follow-up time was 45.4 and 44.6 months in all participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT population
Arm/Group Title Investigator's Choice Chemotherapy Veliparib + Carboplatin + Paclitaxel
Hide Arm/Group Description:

Participants received Investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:

  • Carboplatin AUC 6 mg/mL*min + paclitaxel 200 mg/m²
  • Cisplatin 75 mg/m² + pemetrexed 500 mg/m²
  • Carboplatin AUC 6 or AUC 5 mg/mL*min + pemetrexed 500 mg/m²

After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.

Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.

After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
Overall Number of Participants Analyzed 297 298
Median (95% Confidence Interval)
Unit of Measure: months
12.1
(10.0 to 13.7)
12.1
(10.4 to 14.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigator's Choice Chemotherapy, Veliparib + Carboplatin + Paclitaxel
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.846
Comments [Not Specified]
Method Log Rank
Comments Log rank test stratified by LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.986
Confidence Interval (2-Sided) 95%
0.827 to 1.176
Estimation Comments The hazard ratio was obtained using the covariate adjusted Cox Proportional Hazard Model with covariates of LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.
5.Secondary Outcome
Title Progression Free Survival (PFS) in All Participants
Hide Description

Progression-free survival is defined as the time from the date of randomization to the date of disease progression (PD) per RECIST version 1.1 or death (all causes of mortality), whichever occurred first.

PD: At least a 20% increase in the size of target lesions, taking as reference the smallest size recorded since the treatment started (Baseline or after) with an absolute increase of at least 5 mm, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.

PFS was estimated using Kaplan-Meier methodology. Participants who did not have an event of disease progression or had not died on or before the cut-off date were censored at the date of their last disease progression assessment on or before the cut-off date. Any PD and death occurring > 26 weeks and > 12 weeks after the previous assessment, respectively, were excluded and patients were censored at last assessment before PD or death.
Time Frame From randomization up to the data cut-off date of 15 July 2019; the median follow-up time was 45.4 and 44.6 months in all participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT population
Arm/Group Title Investigator's Choice Chemotherapy Veliparib + Carboplatin + Paclitaxel
Hide Arm/Group Description:

Participants received Investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:

  • Carboplatin AUC 6 mg/mL*min + paclitaxel 200 mg/m²
  • Cisplatin 75 mg/m² + pemetrexed 500 mg/m²
  • Carboplatin AUC 6 or AUC 5 mg/mL*min + pemetrexed 500 mg/m²

After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.

Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.

After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
Overall Number of Participants Analyzed 297 298
Median (95% Confidence Interval)
Unit of Measure: months
6.7
(5.6 to 7.2)
5.9
(5.0 to 6.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigator's Choice Chemotherapy, Veliparib + Carboplatin + Paclitaxel
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.473
Comments [Not Specified]
Method Log Rank
Comments Log rank test stratified by LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.035
Confidence Interval (2-Sided) 95%
0.867 to 1.235
Estimation Comments The hazard ratio was obtained using the covariate adjusted Cox Proportional Hazard Model with covariates of LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.
6.Secondary Outcome
Title Objective Response Rate (ORR) in All Participants
Hide Description

Objective response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) per RECIST version 1.1 criteria. Response must have been confirmed at a consecutive assessment 28 days or more after the assessment at which response was first observed.

CR: The disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters, persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, or any new lesions.
Time Frame Assessed on Day 1 of Cycles 3 and 5 then every 9 weeks for 1 year or until maintenance therapy was discontinued, then every 12 weeks until radiographic progression or death; median time on follow-up was 6.7 and 5.9 months in each group, respectively.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT population
Arm/Group Title Investigator's Choice Chemotherapy Veliparib + Carboplatin + Paclitaxel
Hide Arm/Group Description:

Participants received Investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:

  • Carboplatin AUC 6 mg/mL*min + paclitaxel 200 mg/m²
  • Cisplatin 75 mg/m² + pemetrexed 500 mg/m²
  • Carboplatin AUC 6 or AUC 5 mg/mL*min + pemetrexed 500 mg/m²

After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.

Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.

After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
Overall Number of Participants Analyzed 297 298
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
29.0
(23.9 to 34.5)
26.2
(21.3 to 31.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigator's Choice Chemotherapy, Veliparib + Carboplatin + Paclitaxel
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.409
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression adjusted for the covariates of LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.59 to 1.24
Estimation Comments Odds ratio is from covariate adjusted logistic regression with the covariates being LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.
Time Frame All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
Adverse Event Reporting Description All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
 
Arm/Group Title Investigator's Choice Chemotherapy Veliparib + Carboplatin + Paclitaxel
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Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:

  • Carboplatin AUC 6 mg/mL*min + paclitaxel 200 mg/m²
  • Cisplatin 75 mg/m² + pemetrexed 500 mg/m²
  • Carboplatin AUC 6 or AUC 5 mg/mL*min + pemetrexed 500 mg/m²

After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.

Participants received 120 mg veliparib twice a day (BID) on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.

After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
All-Cause Mortality
Investigator's Choice Chemotherapy Veliparib + Carboplatin + Paclitaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   255/297 (85.86%)      250/298 (83.89%)    
Hide Serious Adverse Events
Investigator's Choice Chemotherapy Veliparib + Carboplatin + Paclitaxel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   98/288 (34.03%)      121/293 (41.30%)    
Blood and lymphatic system disorders     
ANAEMIA † 1  15/288 (5.21%)  17 7/293 (2.39%)  8
FEBRILE NEUTROPENIA † 1  7/288 (2.43%)  10 13/293 (4.44%)  15
LEUKOPENIA † 1  0/288 (0.00%)  0 2/293 (0.68%)  2
LYMPHADENITIS † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
NEUTROPENIA † 1  5/288 (1.74%)  5 6/293 (2.05%)  9
PANCYTOPENIA † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
THROMBOCYTOPENIA † 1  6/288 (2.08%)  6 2/293 (0.68%)  2
Cardiac disorders     
ARTERIOSPASM CORONARY † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
ATRIAL FIBRILLATION † 1  2/288 (0.69%)  2 4/293 (1.37%)  4
ATRIAL FLUTTER † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
CARDIAC ARREST † 1  2/288 (0.69%)  2 0/293 (0.00%)  0
CARDIAC FAILURE † 1  1/288 (0.35%)  1 1/293 (0.34%)  1
CARDIAC FAILURE ACUTE † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
CARDIO-RESPIRATORY ARREST † 1  1/288 (0.35%)  1 1/293 (0.34%)  1
CARDIOPULMONARY FAILURE † 1  1/288 (0.35%)  1 2/293 (0.68%)  2
LEFT VENTRICULAR FAILURE † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
PERICARDIAL EFFUSION † 1  0/288 (0.00%)  0 7/293 (2.39%)  7
PERICARDITIS † 1  1/288 (0.35%)  2 0/293 (0.00%)  0
SUPRAVENTRICULAR TACHYCARDIA † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
Gastrointestinal disorders     
ABDOMINAL PAIN † 1  2/288 (0.69%)  4 2/293 (0.68%)  2
APHTHOUS ULCER † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
ASCITES † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
COLITIS ISCHAEMIC † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
COLITIS ULCERATIVE † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
CONSTIPATION † 1  1/288 (0.35%)  1 2/293 (0.68%)  2
DIARRHOEA † 1  2/288 (0.69%)  2 2/293 (0.68%)  2
GASTRITIS † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
HAEMATEMESIS † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
INTESTINAL OBSTRUCTION † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
MESENTERIC VEIN THROMBOSIS † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
NAUSEA † 1  3/288 (1.04%)  3 3/293 (1.02%)  3
OESOPHAGEAL STENOSIS † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
OESOPHAGITIS † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
RECTAL HAEMORRHAGE † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
VOMITING † 1  5/288 (1.74%)  5 6/293 (2.05%)  6
General disorders     
ASTHENIA † 1  2/288 (0.69%)  2 1/293 (0.34%)  2
CATHETER SITE HAEMORRHAGE † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
CHEST PAIN † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
DISEASE PROGRESSION † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
FATIGUE † 1  2/288 (0.69%)  2 0/293 (0.00%)  0
GENERAL PHYSICAL HEALTH DETERIORATION † 1  1/288 (0.35%)  2 0/293 (0.00%)  0
MALAISE † 1  3/288 (1.04%)  6 0/293 (0.00%)  0
MULTIPLE ORGAN DYSFUNCTION SYNDROME † 1  2/288 (0.69%)  2 0/293 (0.00%)  0
NON-CARDIAC CHEST PAIN † 1  0/288 (0.00%)  0 2/293 (0.68%)  2
PERIPHERAL SWELLING † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
PYREXIA † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
SUDDEN DEATH † 1  1/288 (0.35%)  1 2/293 (0.68%)  2
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
Hepatobiliary disorders     
HEPATIC FUNCTION ABNORMAL † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
Immune system disorders     
ANAPHYLACTIC SHOCK † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
DRUG HYPERSENSITIVITY † 1  1/288 (0.35%)  1 3/293 (1.02%)  4
Infections and infestations     
ABDOMINAL ABSCESS † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
APPENDICITIS PERFORATED † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
BACTERAEMIA † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
BRONCHITIS † 1  1/288 (0.35%)  1 1/293 (0.34%)  1
CELLULITIS † 1  1/288 (0.35%)  1 1/293 (0.34%)  1
CLOSTRIDIUM DIFFICILE COLITIS † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
DEVICE RELATED INFECTION † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
DIARRHOEA INFECTIOUS † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
EMPYEMA † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
GASTROENTERITIS † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
HERPES ZOSTER † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
INFECTION † 1  2/288 (0.69%)  2 0/293 (0.00%)  0
INFLUENZA † 1  0/288 (0.00%)  0 2/293 (0.68%)  2
LOWER RESPIRATORY TRACT INFECTION † 1  1/288 (0.35%)  1 4/293 (1.37%)  4
LUNG INFECTION † 1  0/288 (0.00%)  0 2/293 (0.68%)  2
LYMPHANGITIS † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
NEUTROPENIC SEPSIS † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
PERITONSILLAR ABSCESS † 1  1/288 (0.35%)  2 0/293 (0.00%)  0
PNEUMONIA † 1  8/288 (2.78%)  9 19/293 (6.48%)  26
PNEUMONIA BACTERIAL † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
PNEUMONIA PSEUDOMONAL † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
PSEUDOMONAL SEPSIS † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
PULMONARY SEPSIS † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
PYELONEPHRITIS † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
RESPIRATORY TRACT INFECTION † 1  1/288 (0.35%)  1 1/293 (0.34%)  1
SEPSIS † 1  4/288 (1.39%)  5 1/293 (0.34%)  1
SEPTIC SHOCK † 1  1/288 (0.35%)  1 2/293 (0.68%)  2
UPPER RESPIRATORY TRACT INFECTION † 1  0/288 (0.00%)  0 1/293 (0.34%)  2
URINARY TRACT INFECTION † 1  2/288 (0.69%)  2 2/293 (0.68%)  2
VASCULAR DEVICE INFECTION † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
VIRAL UPPER RESPIRATORY TRACT INFECTION † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
Injury, poisoning and procedural complications     
FALL † 1  1/288 (0.35%)  1 1/293 (0.34%)  1
FEMORAL NECK FRACTURE † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
HEART INJURY † 1  0/288 (0.00%)  0 1/293 (0.34%)  2
HIP FRACTURE † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
LUMBAR VERTEBRAL FRACTURE † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
RADIATION OESOPHAGITIS † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
SPINAL COMPRESSION FRACTURE † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
Investigations     
C-REACTIVE PROTEIN INCREASED † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
Metabolism and nutrition disorders     
DECREASED APPETITE † 1  2/288 (0.69%)  2 2/293 (0.68%)  2
DEHYDRATION † 1  6/288 (2.08%)  6 0/293 (0.00%)  0
HYPOCALCAEMIA † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
HYPOGLYCAEMIA † 1  1/288 (0.35%)  1 1/293 (0.34%)  1
HYPONATRAEMIA † 1  2/288 (0.69%)  2 1/293 (0.34%)  1
TYPE 2 DIABETES MELLITUS † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
Musculoskeletal and connective tissue disorders     
ARTHRALGIA † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
BACK PAIN † 1  2/288 (0.69%)  2 3/293 (1.02%)  3
BONE PAIN † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
MUSCULOSKELETAL CHEST PAIN † 1  1/288 (0.35%)  2 1/293 (0.34%)  1
MUSCULOSKELETAL PAIN † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
PAIN IN EXTREMITY † 1  1/288 (0.35%)  1 1/293 (0.34%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
CANCER PAIN † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
GASTRIC CANCER † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
MALIGNANT NEOPLASM PROGRESSION † 1  10/288 (3.47%)  12 14/293 (4.78%)  19
MALIGNANT PLEURAL EFFUSION † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
METASTASES TO BONE † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
METASTASES TO CENTRAL NERVOUS SYSTEM † 1  1/288 (0.35%)  1 4/293 (1.37%)  4
METASTASES TO MENINGES † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
PERICARDIAL EFFUSION MALIGNANT † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
Nervous system disorders     
CEREBRAL INFARCTION † 1  0/288 (0.00%)  0 2/293 (0.68%)  2
CEREBRAL ISCHAEMIA † 1  0/288 (0.00%)  0 1/293 (0.34%)  2
CEREBROVASCULAR ACCIDENT † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
COGNITIVE DISORDER † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
PERIPHERAL SENSORY NEUROPATHY † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
SPINAL CORD COMPRESSION † 1  1/288 (0.35%)  1 1/293 (0.34%)  1
Psychiatric disorders     
CONFUSIONAL STATE † 1  1/288 (0.35%)  1 1/293 (0.34%)  1
DELIRIUM † 1  0/288 (0.00%)  0 2/293 (0.68%)  2
DEPRESSION † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
DISORIENTATION † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
Renal and urinary disorders     
ACUTE KIDNEY INJURY † 1  1/288 (0.35%)  1 1/293 (0.34%)  1
AZOTAEMIA † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
HAEMATURIA † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
RENAL FAILURE † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
RENAL IMPAIRMENT † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
URINARY RETENTION † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
ACUTE RESPIRATORY FAILURE † 1  1/288 (0.35%)  2 2/293 (0.68%)  2
CHRONIC OBSTRUCTIVE PULMONARY DISEASE † 1  1/288 (0.35%)  1 2/293 (0.68%)  2
DYSPNOEA † 1  7/288 (2.43%)  9 8/293 (2.73%)  8
DYSPNOEA EXERTIONAL † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
HAEMOPTYSIS † 1  3/288 (1.04%)  3 1/293 (0.34%)  1
HYPOXIA † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
ORGANISING PNEUMONIA † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
PLEURAL EFFUSION † 1  6/288 (2.08%)  9 5/293 (1.71%)  7
PLEURITIC PAIN † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
PNEUMONIA ASPIRATION † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
PNEUMOTHORAX † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
PRODUCTIVE COUGH † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
PULMONARY EMBOLISM † 1  6/288 (2.08%)  6 5/293 (1.71%)  5
PULMONARY HAEMORRHAGE † 1  2/288 (0.69%)  2 0/293 (0.00%)  0
RESPIRATORY DISTRESS † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
RESPIRATORY FAILURE † 1  2/288 (0.69%)  3 2/293 (0.68%)  2
RHINORRHOEA † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
Skin and subcutaneous tissue disorders     
SUBCUTANEOUS EMPHYSEMA † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
Vascular disorders     
ANEURYSM † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
AXILLARY VEIN THROMBOSIS † 1  0/288 (0.00%)  0 1/293 (0.34%)  1
DEEP VEIN THROMBOSIS † 1  2/288 (0.69%)  2 0/293 (0.00%)  0
HYPOTENSION † 1  1/288 (0.35%)  1 2/293 (0.68%)  2
HYPOVOLAEMIC SHOCK † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
ORTHOSTATIC HYPOTENSION † 1  2/288 (0.69%)  2 0/293 (0.00%)  0
VENOUS THROMBOSIS † 1  1/288 (0.35%)  1 0/293 (0.00%)  0
1
Term from vocabulary, MedDRA 21.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Investigator's Choice Chemotherapy Veliparib + Carboplatin + Paclitaxel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   269/288 (93.40%)      275/293 (93.86%)    
Blood and lymphatic system disorders     
ANAEMIA † 1  107/288 (37.15%)  197 112/293 (38.23%)  212
LEUKOPENIA † 1  40/288 (13.89%)  77 43/293 (14.68%)  77
NEUTROPENIA † 1  89/288 (30.90%)  175 104/293 (35.49%)  210
THROMBOCYTOPENIA † 1  54/288 (18.75%)  102 76/293 (25.94%)  155
Gastrointestinal disorders     
CONSTIPATION † 1  92/288 (31.94%)  113 69/293 (23.55%)  81
DIARRHOEA † 1  47/288 (16.32%)  60 51/293 (17.41%)  70
NAUSEA † 1  131/288 (45.49%)  202 86/293 (29.35%)  121
STOMATITIS † 1  30/288 (10.42%)  32 19/293 (6.48%)  24
VOMITING † 1  73/288 (25.35%)  99 39/293 (13.31%)  48
General disorders     
ASTHENIA † 1  30/288 (10.42%)  50 29/293 (9.90%)  58
FATIGUE † 1  89/288 (30.90%)  117 80/293 (27.30%)  108
OEDEMA PERIPHERAL † 1  24/288 (8.33%)  36 13/293 (4.44%)  16
PYREXIA † 1  16/288 (5.56%)  21 15/293 (5.12%)  17
Investigations     
WEIGHT DECREASED † 1  24/288 (8.33%)  25 14/293 (4.78%)  17
Metabolism and nutrition disorders     
DECREASED APPETITE † 1  79/288 (27.43%)  109 63/293 (21.50%)  79
HYPERGLYCAEMIA † 1  11/288 (3.82%)  15 24/293 (8.19%)  24
HYPOMAGNESAEMIA † 1  16/288 (5.56%)  19 21/293 (7.17%)  22
HYPONATRAEMIA † 1  12/288 (4.17%)  14 16/293 (5.46%)  18
Musculoskeletal and connective tissue disorders     
ARTHRALGIA † 1  26/288 (9.03%)  35 39/293 (13.31%)  45
BACK PAIN † 1  22/288 (7.64%)  24 17/293 (5.80%)  21
BONE PAIN † 1  9/288 (3.13%)  13 15/293 (5.12%)  21
MYALGIA † 1  17/288 (5.90%)  22 38/293 (12.97%)  50
PAIN IN EXTREMITY † 1  15/288 (5.21%)  19 15/293 (5.12%)  17
Nervous system disorders     
DIZZINESS † 1  22/288 (7.64%)  25 17/293 (5.80%)  17
DYSGEUSIA † 1  29/288 (10.07%)  33 19/293 (6.48%)  20
PERIPHERAL SENSORY NEUROPATHY † 1  42/288 (14.58%)  51 131/293 (44.71%)  195
Psychiatric disorders     
INSOMNIA † 1  30/288 (10.42%)  30 37/293 (12.63%)  39
Respiratory, thoracic and mediastinal disorders     
COUGH † 1  29/288 (10.07%)  31 27/293 (9.22%)  32
DYSPNOEA † 1  25/288 (8.68%)  30 42/293 (14.33%)  46
HICCUPS † 1  21/288 (7.29%)  29 17/293 (5.80%)  27
OROPHARYNGEAL PAIN † 1  15/288 (5.21%)  16 6/293 (2.05%)  8
Skin and subcutaneous tissue disorders     
ALOPECIA † 1  34/288 (11.81%)  40 137/293 (46.76%)  160
RASH † 1  25/288 (8.68%)  29 13/293 (4.44%)  16
1
Term from vocabulary, MedDRA 21.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
EMail: abbvieclinicaltrials@abbvie.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02264990    
Other Study ID Numbers: M14-359
2014-002565-30 ( EudraCT Number )
First Submitted: October 9, 2014
First Posted: October 15, 2014
Results First Submitted: February 8, 2021
Results First Posted: February 26, 2021
Last Update Posted: February 26, 2021