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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)

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ClinicalTrials.gov Identifier: NCT02412371
Recruitment Status : Terminated (Phase 2 was not conducted due to a change in the standard of care for newly diagnosed, unresectable Stage III NSCLC)
First Posted : April 9, 2015
Results First Posted : July 22, 2020
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-small Cell Lung Cancer Stage III
Interventions Drug: Paclitaxel
Drug: Placebo for Veliparib
Drug: Carboplatin
Drug: Veliparib
Radiation: Radiotherapy
Enrollment 48
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.
Pre-assignment Details

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.

Arm/Group Title Veliparib 60 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 80 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 120 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 200 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 240 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 240 mg BID + CRT -> Veliparib 240 mg BID + CT
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 7 9 7 8 12 5
Completed [1] 0 0 0 0 0 0
Not Completed 7 9 7 8 12 5
Reason Not Completed
Withdrawal by Subject             0             2             0             1             1             0
Sponsor Discontinued Study             1             4             6             4             5             0
Death             4             2             1             3             5             2
Other             2             1             0             0             1             3
[1]
Completed indicates participants remaining on study.
Arm/Group Title Veliparib 60 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 80 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 120 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 200 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 240 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 240 mg BID + CRT -> Veliparib 240 mg BID + CT Total
Hide Arm/Group Description

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.

Total of all reporting groups
Overall Number of Baseline Participants 7 9 7 8 12 5 48
Hide Baseline Analysis Population Description
All enrolled participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 9 participants 7 participants 8 participants 12 participants 5 participants 48 participants
69.1  (6.39) 65.7  (7.55) 66.9  (9.84) 59.8  (6.07) 67.3  (9.39) 65.6  (11.84) 65.8  (8.60)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 9 participants 7 participants 8 participants 12 participants 5 participants 48 participants
40 - < 60 years
0
   0.0%
1
  11.1%
2
  28.6%
3
  37.5%
2
  16.7%
1
  20.0%
9
  18.8%
≥ 60 years
7
 100.0%
8
  88.9%
5
  71.4%
5
  62.5%
10
  83.3%
4
  80.0%
39
  81.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 9 participants 7 participants 8 participants 12 participants 5 participants 48 participants
Female
4
  57.1%
6
  66.7%
5
  71.4%
6
  75.0%
5
  41.7%
3
  60.0%
29
  60.4%
Male
3
  42.9%
3
  33.3%
2
  28.6%
2
  25.0%
7
  58.3%
2
  40.0%
19
  39.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 9 participants 7 participants 8 participants 12 participants 5 participants 48 participants
White
6
  85.7%
9
 100.0%
6
  85.7%
8
 100.0%
11
  91.7%
3
  60.0%
43
  89.6%
Black
1
  14.3%
0
   0.0%
1
  14.3%
0
   0.0%
1
   8.3%
2
  40.0%
5
  10.4%
Eastern Cooperative Oncology Group (ECOG) Performance Score   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 9 participants 7 participants 8 participants 12 participants 5 participants 48 participants
Grade 0 (Fully active)
3
  42.9%
3
  33.3%
3
  42.9%
4
  50.0%
6
  50.0%
4
  80.0%
23
  47.9%
Grade 1 (Restricted but ambulatory)
4
  57.1%
6
  66.7%
4
  57.1%
4
  50.0%
6
  50.0%
1
  20.0%
25
  52.1%
[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 (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)
1.Primary Outcome
Title Number of Participants With Dose-limiting Toxicities (DLTs)
Hide Description

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
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of veliparib
Arm/Group Title Veliparib 60 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 80 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 120 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 200 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 240 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 240 mg BID + CRT -> Veliparib 240 mg BID + CT
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 7 9 7 8 12 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
2
  40.0%
2.Secondary Outcome
Title Objective Response Rate
Hide Description

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.

Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of veliparib and with at least one post-baseline tumor assessment
Arm/Group Title Veliparib 60 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 80 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 120 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 200 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 240 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 240 mg BID + CRT -> Veliparib 240 mg BID + CT
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 6 8 7 8 11 3
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
50.0
(11.8 to 88.2)
50.0
(15.7 to 84.3)
100.0
(59.0 to 100)
62.5
(24.5 to 91.5)
72.7
(39.0 to 94.0)
0.0
(0.0 to 70.8)
3.Post-Hoc Outcome
Title Progression-free Survival
Hide Description

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.

Time Frame From first dose until end of study; maximum time on follow-up was approximately 46 months.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Total
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 48
Median (95% Confidence Interval)
Unit of Measure: months
19.6
(9.7 to 32.6)
4.Post-Hoc Outcome
Title Overall Survival
Hide Description 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.
Time Frame From first dose of study drug until end of study; maximum time on follow-up was approximately 46 months.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Total
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 48
Median (95% Confidence Interval)
Unit of Measure: months
32.6 [1] 
(15.0 to NA)
[1]
Could not be calculated due to the low number of events
5.Post-Hoc Outcome
Title Duration of Overall Response (DOR)
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Total
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 27
Median (95% Confidence Interval)
Unit of Measure: months
30.4 [1] 
(17.5 to NA)
[1]
Could not be estimated due to the low number of events
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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Veliparib 60 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 80 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 120 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 200 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 240 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 240 mg BID + CRT -> Veliparib 240 mg BID + CT
Hide Arm/Group Description

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.

All-Cause Mortality
Veliparib 60 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 80 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 120 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 200 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 240 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 240 mg BID + CRT -> Veliparib 240 mg BID + CT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/7 (71.43%)      3/9 (33.33%)      1/7 (14.29%)      3/8 (37.50%)      6/12 (50.00%)      3/5 (60.00%)    
Hide Serious Adverse Events
Veliparib 60 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 80 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 120 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 200 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 240 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 240 mg BID + CRT -> Veliparib 240 mg BID + CT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/7 (28.57%)      5/9 (55.56%)      4/7 (57.14%)      3/8 (37.50%)      3/12 (25.00%)      2/5 (40.00%)    
Blood and lymphatic system disorders             
FEBRILE NEUTROPENIA  1  0/7 (0.00%)  0 1/9 (11.11%)  1 1/7 (14.29%)  1 0/8 (0.00%)  0 0/12 (0.00%)  0 1/5 (20.00%)  3
Cardiac disorders             
CARDIAC ARREST  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 1/5 (20.00%)  1
CARDIAC TAMPONADE  1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
Gastrointestinal disorders             
DIARRHOEA  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/8 (12.50%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0
NAUSEA  1  0/7 (0.00%)  0 1/9 (11.11%)  1 0/7 (0.00%)  0 1/8 (12.50%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0
OESOPHAGEAL OBSTRUCTION  1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
OESOPHAGEAL STENOSIS  1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
OESOPHAGITIS  1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 0/8 (0.00%)  0 0/12 (0.00%)  0 1/5 (20.00%)  1
VOMITING  1  1/7 (14.29%)  2 0/9 (0.00%)  0 0/7 (0.00%)  0 1/8 (12.50%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0
General disorders             
NON-CARDIAC CHEST PAIN  1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
PYREXIA  1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 1/8 (12.50%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0
Infections and infestations             
PNEUMONIA  1  0/7 (0.00%)  0 1/9 (11.11%)  1 1/7 (14.29%)  1 1/8 (12.50%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0
SEPSIS  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/8 (12.50%)  1 0/12 (0.00%)  0 1/5 (20.00%)  1
Injury, poisoning and procedural complications             
RADIATION PNEUMONITIS  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 2/12 (16.67%)  2 0/5 (0.00%)  0
Metabolism and nutrition disorders             
DEHYDRATION  1  1/7 (14.29%)  1 2/9 (22.22%)  2 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  2 0/5 (0.00%)  0
Musculoskeletal and connective tissue disorders             
BACK PAIN  1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
HAEMOPTYSIS  1  0/7 (0.00%)  0 1/9 (11.11%)  1 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
PNEUMONIA ASPIRATION  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/8 (12.50%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0
PULMONARY OEDEMA  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/8 (12.50%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Veliparib 60 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 80 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 120 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 200 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 240 mg BID + CRT -> Veliparib 120 mg BID + CT Veliparib 240 mg BID + CRT -> Veliparib 240 mg BID + CT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/7 (100.00%)      9/9 (100.00%)      7/7 (100.00%)      8/8 (100.00%)      12/12 (100.00%)      5/5 (100.00%)    
Blood and lymphatic system disorders             
ANAEMIA  1  3/7 (42.86%)  9 3/9 (33.33%)  4 3/7 (42.86%)  6 1/8 (12.50%)  3 6/12 (50.00%)  11 3/5 (60.00%)  10
FEBRILE NEUTROPENIA  1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 1/8 (12.50%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0
LEUKOCYTOSIS  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
LEUKOPENIA  1  3/7 (42.86%)  3 4/9 (44.44%)  7 3/7 (42.86%)  12 2/8 (25.00%)  6 7/12 (58.33%)  16 4/5 (80.00%)  9
LYMPHOPENIA  1  1/7 (14.29%)  3 2/9 (22.22%)  5 1/7 (14.29%)  1 3/8 (37.50%)  4 5/12 (41.67%)  17 2/5 (40.00%)  4
NEUTROPENIA  1  3/7 (42.86%)  4 6/9 (66.67%)  7 6/7 (85.71%)  12 4/8 (50.00%)  6 9/12 (75.00%)  15 4/5 (80.00%)  7
THROMBOCYTOPENIA  1  2/7 (28.57%)  2 6/9 (66.67%)  8 3/7 (42.86%)  7 3/8 (37.50%)  6 9/12 (75.00%)  18 4/5 (80.00%)  6
Cardiac disorders             
ANGINA PECTORIS  1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
ATRIAL FIBRILLATION  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/8 (12.50%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0
PALPITATIONS  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
SINUS TACHYCARDIA  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
TACHYCARDIA  1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  2 0/8 (0.00%)  0 1/12 (8.33%)  2 0/5 (0.00%)  0
VENTRICULAR TACHYCARDIA  1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
Ear and labyrinth disorders             
EXTERNAL EAR PAIN  1  0/7 (0.00%)  0 1/9 (11.11%)  1 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
TINNITUS  1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
Eye disorders             
DRY EYE  1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 1/8 (12.50%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0
VISION BLURRED  1  1/7 (14.29%)  1 1/9 (11.11%)  1 1/7 (14.29%)  1 1/8 (12.50%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0
VITREOUS FLOATERS  1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
Gastrointestinal disorders             
ABDOMINAL DISTENSION  1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
ABDOMINAL PAIN LOWER  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 1/5 (20.00%)  1
CONSTIPATION  1  4/7 (57.14%)  5 2/9 (22.22%)  2 2/7 (28.57%)  3 4/8 (50.00%)  9 3/12 (25.00%)  3 4/5 (80.00%)  5
DIARRHOEA  1  4/7 (57.14%)  4 2/9 (22.22%)  2 2/7 (28.57%)  4 1/8 (12.50%)  1 4/12 (33.33%)  6 1/5 (20.00%)  1
DRY MOUTH  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 2/12 (16.67%)  3 1/5 (20.00%)  1
DYSPEPSIA  1  1/7 (14.29%)  2 0/9 (0.00%)  0 1/7 (14.29%)  1 1/8 (12.50%)  1 1/12 (8.33%)  1 0/5 (0.00%)  0
DYSPHAGIA  1  5/7 (71.43%)  7 1/9 (11.11%)  1 4/7 (57.14%)  4 7/8 (87.50%)  12 3/12 (25.00%)  3 2/5 (40.00%)  3
FLATULENCE  1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
GASTROOESOPHAGEAL REFLUX DISEASE  1  1/7 (14.29%)  1 1/9 (11.11%)  1 1/7 (14.29%)  2 1/8 (12.50%)  1 2/12 (16.67%)  2 1/5 (20.00%)  1
GINGIVAL BLEEDING  1  0/7 (0.00%)  0 1/9 (11.11%)  1 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
HAEMORRHOIDS  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
NAUSEA  1  3/7 (42.86%)  4 5/9 (55.56%)  8 5/7 (71.43%)  10 4/8 (50.00%)  6 10/12 (83.33%)  16 5/5 (100.00%)  9
ODYNOPHAGIA  1  0/7 (0.00%)  0 1/9 (11.11%)  1 1/7 (14.29%)  1 2/8 (25.00%)  2 1/12 (8.33%)  1 0/5 (0.00%)  0
OESOPHAGEAL PAIN  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/8 (12.50%)  1 1/12 (8.33%)  1 0/5 (0.00%)  0
OESOPHAGEAL STENOSIS  1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
OESOPHAGEAL ULCER  1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 1/8 (12.50%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0
OESOPHAGITIS  1  4/7 (57.14%)  4 6/9 (66.67%)  7 4/7 (57.14%)  7 4/8 (50.00%)  5 9/12 (75.00%)  10 3/5 (60.00%)  4
ORAL PAIN  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
STOMATITIS  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 1/5 (20.00%)  1
VOMITING  1  1/7 (14.29%)  1 4/9 (44.44%)  6 2/7 (28.57%)  3 2/8 (25.00%)  5 4/12 (33.33%)  7 3/5 (60.00%)  8
General disorders             
ASTHENIA  1  1/7 (14.29%)  1 0/9 (0.00%)  0 1/7 (14.29%)  1 1/8 (12.50%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0
CATHETER SITE PAIN  1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
CHEST PAIN  1  1/7 (14.29%)  1 1/9 (11.11%)  1 1/7 (14.29%)  2 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
CHILLS  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/8 (12.50%)  1 2/12 (16.67%)  2 0/5 (0.00%)  0
EXTRAVASATION  1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
FATIGUE  1  6/7 (85.71%)  9 6/9 (66.67%)  6 5/7 (71.43%)  8 3/8 (37.50%)  3 7/12 (58.33%)  11 5/5 (100.00%)  7
FEELING HOT  1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
GRAVITATIONAL OEDEMA  1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
INJECTION SITE REACTION  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
LOCALISED OEDEMA  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 1/5 (20.00%)  1
MALAISE  1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
MEDICAL DEVICE SITE ERYTHEMA  1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
MUCOSAL DRYNESS  1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
MUCOSAL INFLAMMATION  1  0/7 (0.00%)  0 1/9 (11.11%)  1 0/7 (0.00%)  0 1/8 (12.50%)  1 0/12 (0.00%)  0 1/5 (20.00%)  1
NON-CARDIAC CHEST PAIN  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 3/12 (25.00%)  4 1/5 (20.00%)  2
OEDEMA PERIPHERAL  1  0/7 (0.00%)  0 1/9 (11.11%)  1 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
PERFORMANCE STATUS DECREASED  1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
PERIPHERAL SWELLING  1  0/7 (0.00%)  0 1/9 (11.11%)  1 1/7 (14.29%)  1 2/8 (25.00%)  2 0/12 (0.00%)  0 0/5 (0.00%)  0
PYREXIA  1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  3 1/8 (12.50%)  1 1/12 (8.33%)  1 1/5 (20.00%)  1
SWELLING FACE  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
Immune system disorders             
DRUG HYPERSENSITIVITY  1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 0/8 (0.00%)  0 0/12 (0.00%)  0 1/5 (20.00%)  1
Infections and infestations             
BACTERAEMIA  1  0/7 (0.00%)  0 1/9 (11.11%)  1 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
BRONCHITIS  1  0/7 (0.00%)  0 3/9 (33.33%)  3 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
CANDIDA INFECTION  1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
CATHETER SITE CELLULITIS  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
CATHETER SITE INFECTION  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
DIARRHOEA INFECTIOUS  1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
FUNGAL INFECTION  1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
HERPES SIMPLEX OESOPHAGITIS  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/8 (12.50%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0
HERPES ZOSTER  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
INFLUENZA  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/8 (12.50%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0
LARYNGITIS  1  0/7 (0.00%)  0 1/9 (11.11%)  1 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
NASOPHARYNGITIS  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/8 (12.50%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0
OESOPHAGEAL CANDIDIASIS  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 1/5 (20.00%)  1
ORAL CANDIDIASIS  1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 1/8 (12.50%)  1 1/12 (8.33%)  1 0/5 (0.00%)  0
OTITIS EXTERNA  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
PNEUMONIA  1  0/7 (0.00%)  0 1/9 (11.11%)  1 0/7 (0.00%)  0 1/8 (12.50%)  1 3/12 (25.00%)  3 0/5 (0.00%)  0
UPPER RESPIRATORY TRACT INFECTION  1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
URINARY TRACT INFECTION  1  1/7 (14.29%)  1 1/9 (11.11%)  1 1/7 (14.29%)  1 0/8 (0.00%)  0 0/12 (0.00%)  0 1/5 (20.00%)  1
VULVOVAGINAL CANDIDIASIS  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 1/5 (20.00%)  1
Injury, poisoning and procedural complications             
FALL  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
INCISION SITE COMPLICATION  1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
INFUSION RELATED REACTION  1  0/7 (0.00%)  0 1/9 (11.11%)  1 0/7 (0.00%)  0 1/8 (12.50%)  1 1/12 (8.33%)  1 0/5 (0.00%)  0
MUSCLE STRAIN  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
RADIATION INJURY  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
RADIATION OESOPHAGITIS  1  0/7 (0.00%)  0 1/9 (11.11%)  1 0/7 (0.00%)  0 1/8 (12.50%)  2 1/12 (8.33%)  2 0/5 (0.00%)  0
RADIATION PNEUMONITIS  1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
RADIATION SKIN INJURY  1  2/7 (28.57%)  4 2/9 (22.22%)  2 0/7 (0.00%)  0 0/8 (0.00%)  0 2/12 (16.67%)  2 1/5 (20.00%)  1
Investigations             
ALANINE AMINOTRANSFERASE INCREASED  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 1/5 (20.00%)  1
ASPARTATE AMINOTRANSFERASE INCREASED  1  1/7 (14.29%)  1 0/9 (0.00%)  0 1/7 (14.29%)  1 0/8 (0.00%)  0 1/12 (8.33%)  1 1/5 (20.00%)  1
BLOOD ALKALINE PHOSPHATASE INCREASED  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
BLOOD BILIRUBIN INCREASED  1  0/7 (0.00%)  0 1/9 (11.11%)  1 1/7 (14.29%)  1 1/8 (12.50%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0
BLOOD CREATININE INCREASED  1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
BLOOD GLUCOSE INCREASED  1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  2 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
BLOOD PRESSURE INCREASED  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/8 (12.50%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0
ELECTROCARDIOGRAM QT PROLONGED  1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  3 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
WEIGHT DECREASED  1  2/7 (28.57%)  2 2/9 (22.22%)  3 3/7 (42.86%)  4 3/8 (37.50%)  5 5/12 (41.67%)  11 4/5 (80.00%)  5
Metabolism and nutrition disorders             
DECREASED APPETITE  1  3/7 (42.86%)  3 5/9 (55.56%)  5 3/7 (42.86%)  3 2/8 (25.00%)  2 2/12 (16.67%)  6 3/5 (60.00%)  3
DEHYDRATION  1  1/7 (14.29%)  1 2/9 (22.22%)  2 4/7 (57.14%)  5 2/8 (25.00%)  3 5/12 (41.67%)  5 0/5 (0.00%)  0
HYPERGLYCAEMIA  1  0/7 (0.00%)  0 3/9 (33.33%)  3 1/7 (14.29%)  2 0/8 (0.00%)  0 1/12 (8.33%)  5 0/5 (0.00%)  0
HYPERKALAEMIA  1  0/7 (0.00%)  0 1/9 (11.11%)  1 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
HYPERLIPIDAEMIA  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
HYPERMAGNESAEMIA  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
HYPERTRIGLYCERIDAEMIA  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
HYPOALBUMINAEMIA  1  0/7 (0.00%)  0 0/9 (0.00%)  0 2/7 (28.57%)  2 1/8 (12.50%)  1 1/12 (8.33%)  1 2/5 (40.00%)  3
HYPOCALCAEMIA  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/8 (12.50%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0
HYPOKALAEMIA  1  1/7 (14.29%)  1 1/9 (11.11%)  1 1/7 (14.29%)  3 2/8 (25.00%)  3 4/12 (33.33%)  6 1/5 (20.00%)  1
HYPOMAGNESAEMIA  1  2/7 (28.57%)  2 1/9 (11.11%)  1 1/7 (14.29%)  2 1/8 (12.50%)  1 2/12 (16.67%)  3 1/5 (20.00%)  1
HYPONATRAEMIA  1  0/7 (0.00%)  0 2/9 (22.22%)  2 1/7 (14.29%)  1 0/8 (0.00%)  0 2/12 (16.67%)  2 1/5 (20.00%)  2
HYPOPHAGIA  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/8 (12.50%)  2 1/12 (8.33%)  1 0/5 (0.00%)  0
LACTIC ACIDOSIS  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
Musculoskeletal and connective tissue disorders             
ARTHRALGIA  1  1/7 (14.29%)  1 1/9 (11.11%)  1 0/7 (0.00%)  0 1/8 (12.50%)  1 2/12 (16.67%)  2 1/5 (20.00%)  1
ARTHRITIS  1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
BACK PAIN  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 1/5 (20.00%)  1
BONE PAIN  1  1/7 (14.29%)  1 0/9 (0.00%)  0 1/7 (14.29%)  1 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
COSTOCHONDRITIS  1  0/7 (0.00%)  0 1/9 (11.11%)  1 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
FLANK PAIN  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/8 (12.50%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0
JOINT SWELLING  1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 1/8 (12.50%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0
MUSCLE SPASMS  1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  2 1/8 (12.50%)  2 1/12 (8.33%)  1 0/5 (0.00%)  0
MUSCULAR WEAKNESS  1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 1/8 (12.50%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0
MUSCULOSKELETAL PAIN  1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
MYALGIA  1  0/7 (0.00%)  0 0/9 (0.00%)  0 2/7 (28.57%)  2 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
NECK PAIN  1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 1/5 (20.00%)  1
PAIN IN EXTREMITY  1  0/7 (0.00%)  0 2/9 (22.22%)  2 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
TENDONITIS  1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
BENIGN BREAST NEOPLASM  1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
TUMOUR PAIN  1  0/7 (0.00%)  0 1/9 (11.11%)  1 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
Nervous system disorders             
DIZZINESS  1  1/7 (14.29%)  1 1/9 (11.11%)  1 2/7 (28.57%)  2 3/8 (37.50%)  4 4/12 (33.33%)  4 1/5 (20.00%)  1
DIZZINESS POSTURAL  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
DYSGEUSIA  1  0/7 (0.00%)  0 0/9 (0.00%)  0 2/7 (28.57%)  2 1/8 (12.50%)  1 1/12 (8.33%)  1 1/5 (20.00%)  1
HEADACHE  1  1/7 (14.29%)  1 2/9 (22.22%)  3 3/7 (42.86%)  6 4/8 (50.00%)  4 1/12 (8.33%)  2 0/5 (0.00%)  0
NEURALGIA  1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
PARAESTHESIA  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 1/5 (20.00%)  1
PERIPHERAL MOTOR NEUROPATHY  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/8 (12.50%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0
PERIPHERAL SENSORY NEUROPATHY  1  2/7 (28.57%)  4 1/9 (11.11%)  1 2/7 (28.57%)  3 2/8 (25.00%)  3 1/12 (8.33%)  1 2/5 (40.00%)  4
SYNCOPE  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
TASTE DISORDER  1  0/7 (0.00%)  0 1/9 (11.11%)  1 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
TREMOR  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
Psychiatric disorders             
ANXIETY  1  2/7 (28.57%)  2 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 3/12 (25.00%)  3 0/5 (0.00%)  0
DEPRESSION  1  0/7 (0.00%)  0 1/9 (11.11%)  1 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
INSOMNIA  1  1/7 (14.29%)  2 0/9 (0.00%)  0 2/7 (28.57%)  2 1/8 (12.50%)  1 3/12 (25.00%)  3 1/5 (20.00%)  1
NERVOUSNESS  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/8 (12.50%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0
Renal and urinary disorders             
ACUTE KIDNEY INJURY  1  0/7 (0.00%)  0 1/9 (11.11%)  1 0/7 (0.00%)  0 1/8 (12.50%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0
HAEMATURIA  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
PROTEINURIA  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
URINARY TRACT PAIN  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 1/5 (20.00%)  1
Reproductive system and breast disorders             
VULVOVAGINAL RASH  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/8 (12.50%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
COUGH  1  5/7 (71.43%)  5 3/9 (33.33%)  3 1/7 (14.29%)  1 1/8 (12.50%)  1 3/12 (25.00%)  4 2/5 (40.00%)  2
DYSPHONIA  1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 1/8 (12.50%)  1 1/12 (8.33%)  1 0/5 (0.00%)  0
DYSPNOEA  1  2/7 (28.57%)  2 1/9 (11.11%)  1 2/7 (28.57%)  2 3/8 (37.50%)  3 2/12 (16.67%)  2 2/5 (40.00%)  2
DYSPNOEA EXERTIONAL  1  2/7 (28.57%)  2 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
EPISTAXIS  1  0/7 (0.00%)  0 1/9 (11.11%)  1 0/7 (0.00%)  0 0/8 (0.00%)  0 2/12 (16.67%)  2 1/5 (20.00%)  1
HAEMOPTYSIS  1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 1/8 (12.50%)  2 0/12 (0.00%)  0 1/5 (20.00%)  1
HYPOXIA  1  0/7 (0.00%)  0 1/9 (11.11%)  1 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
OROPHARYNGEAL PAIN  1  1/7 (14.29%)  1 1/9 (11.11%)  1 1/7 (14.29%)  1 1/8 (12.50%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0
PARANASAL SINUS HYPERSECRETION  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
PNEUMOTHORAX  1  0/7 (0.00%)  0 1/9 (11.11%)  1 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
PRODUCTIVE COUGH  1  1/7 (14.29%)  1 0/9 (0.00%)  0 1/7 (14.29%)  1 2/8 (25.00%)  2 0/12 (0.00%)  0 0/5 (0.00%)  0
PULMONARY EMBOLISM  1  0/7 (0.00%)  0 1/9 (11.11%)  1 0/7 (0.00%)  0 0/8 (0.00%)  0 2/12 (16.67%)  2 1/5 (20.00%)  1
RHINORRHOEA  1  0/7 (0.00%)  0 1/9 (11.11%)  1 0/7 (0.00%)  0 1/8 (12.50%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0
SINUS CONGESTION  1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
THROAT IRRITATION  1  0/7 (0.00%)  0 1/9 (11.11%)  1 0/7 (0.00%)  0 1/8 (12.50%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0
WHEEZING  1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 1/8 (12.50%)  1 1/12 (8.33%)  1 0/5 (0.00%)  0
Skin and subcutaneous tissue disorders             
ALOPECIA  1  2/7 (28.57%)  2 1/9 (11.11%)  1 2/7 (28.57%)  2 3/8 (37.50%)  3 2/12 (16.67%)  2 0/5 (0.00%)  0
DERMATITIS  1  0/7 (0.00%)  0 1/9 (11.11%)  1 1/7 (14.29%)  3 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
DRY SKIN  1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
ECCHYMOSIS  1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
ERYTHEMA  1  0/7 (0.00%)  0 0/9 (0.00%)  0 2/7 (28.57%)  2 1/8 (12.50%)  1 1/12 (8.33%)  2 0/5 (0.00%)  0
HYPERHIDROSIS  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
PAIN OF SKIN  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
PRURITUS  1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 2/5 (40.00%)  2
RASH  1  2/7 (28.57%)  5 1/9 (11.11%)  1 0/7 (0.00%)  0 2/8 (25.00%)  2 1/12 (8.33%)  1 1/5 (20.00%)  1
RASH ERYTHEMATOUS  1  1/7 (14.29%)  1 1/9 (11.11%)  1 1/7 (14.29%)  2 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
RASH MACULO-PAPULAR  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
RASH PAPULAR  1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 0/8 (0.00%)  0 0/12 (0.00%)  0 1/5 (20.00%)  1
RASH PRURITIC  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/8 (12.50%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0
SKIN DISCOLOURATION  1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
SKIN EXFOLIATION  1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
SKIN HYPERPIGMENTATION  1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 2/12 (16.67%)  2 1/5 (20.00%)  1
Vascular disorders             
HOT FLUSH  1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 0/8 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0
HYPOTENSION  1  2/7 (28.57%)  2 1/9 (11.11%)  1 1/7 (14.29%)  2 0/8 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
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
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02412371    
Other Study ID Numbers: M14-360
2016-001659-32 ( EudraCT Number )
First Submitted: November 6, 2014
First Posted: April 9, 2015
Results First Submitted: June 9, 2020
Results First Posted: July 22, 2020
Last Update Posted: July 22, 2020