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Study to Evaluate Safety, Pharmacokinetics, and Efficacy of Rociletinib (CO-1686) in Previously Treated Mutant Epidermal Growth Factor Receptor (EGFR) in Non-Small Cell Lung Cancer (NSCLC) Patients

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ClinicalTrials.gov Identifier: NCT01526928
Recruitment Status : Terminated
First Posted : February 6, 2012
Results First Posted : January 6, 2020
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Clovis Oncology, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Locally Advanced or Metastatic Non Small Cell Lung Cancer
Intervention Drug: Rociletinib
Enrollment 612
Recruitment Details There were 612 patients who received rociletinib-111 enrolled in Phase 1 and 501 enrolled in Phase 2. The Phase 1 component of the study was conducted at 8 study sites in the US, Australia, and France. Phase 2 was conducted at 49 study sites in the US, France, Poland, and Australia.
Pre-assignment Details  
Arm/Group Title Rociletinib <900 mg BID FB Capsules Rociletinib 900 mg BID FB Capsules Rociletinib 500 mg BID HBr Tablets Rociletinib 625 mg BID HBr Tablets Rociletinib 750 mg BID HBr Tablets Rociletinib 1000 mg BID HBr Tablets
Hide Arm/Group Description Rociletinib free base (FB) dose <900 mg twice a day (BID). FB doses tested ranged from 150 mg once a day (QD) up to 900 mg twice a day (BID). This arm also includes a 400 mg three times a day (TID) dose. Rociletinib FB capsules were administered in Phase 1 only (until November 2013) and were provided in 50 mg or 150 mg white capsules. Patients were instructed to take each dose with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Patients received rociletinib in 21-day treatment cycles and were treated until there was progression by RECIST v1.1, clinical tumor progression, or unacceptable toxicity, or other discontinuation criteria were met. Patients could opt to continue to receive treatment with rociletinib following radiographic progression as outlined in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of NSCLC with EGFR-TKIs if the patient provided consent, and the investigator and sponsor approved. Rociletinib free base (FB) dose 900 mg twice a day (BID). Rociletinib FB capsules were administered in Phase 1 only (until November 2013) and were provided in 50 mg or 150 mg white capsules. Patients were instructed to take each dose with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Patients received rociletinib in 21-day treatment cycles and were treated until there was progression by RECIST v1.1, clinical tumor progression, or unacceptable toxicity, or other discontinuation criteria were met. Patients could opt to continue to receive treatment with rociletinib following radiographic progression as outlined in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of NSCLC with EGFR-TKIs if the patient provided consent, and the investigator and sponsor approved. Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID). Rociletinib hydrobromide (HBr) tablets were administered in Phase 1 (starting in August 2013) and in all Phase 2 cohorts and were provided in 50 mg or 150 mg white capsules. Patients were instructed to take each dose with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Patients received rociletinib in 21-day cycles and were treated until there was progression by RECIST v1.1, clinical tumor progression, or unacceptable toxicity, or other discontinuation criteria were met. Patients could opt to continue to receive treatment with rociletinib following radiographic progression as outlined in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of NSCLC with EGFR-TKIs if the patient provided consent, and the investigator and sponsor approved. Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID). Rociletinib hydrobromide (HBr) tablets were administered in Phase 1 (starting in August 2013) and in all Phase 2 cohorts and were provided in 50 mg or 150 mg white capsules. Patients were instructed to take each dose with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Patients received rociletinib in 21-day cycles and were treated until there was progression by RECIST v1.1, clinical tumor progression, or unacceptable toxicity, or other discontinuation criteria were met. Patients could opt to continue to receive treatment with rociletinib following radiographic progression as outlined in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of NSCLC with EGFR-TKIs if the patient provided consent, and the investigator and sponsor approved. Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID). Rociletinib hydrobromide (HBr) tablets were administered in Phase 1 (starting in August 2013) and in all Phase 2 cohorts and were provided in 50 mg or 150 mg white capsules. Patients were instructed to take each dose with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Patients received rociletinib in 21-day cycles and were treated until there was progression by RECIST v1.1, clinical tumor progression, or unacceptable toxicity, or other discontinuation criteria were met. Patients could opt to continue to receive treatment with rociletinib following radiographic progression as outlined in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of NSCLC with EGFR-TKIs if the patient provided consent, and the investigator and sponsor approved. Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID). Rociletinib hydrobromide (HBr) tablets were administered in Phase 1 (starting in August 2013) and in all Phase 2 cohorts and were provided in 50 mg or 150 mg white capsules. Patients were instructed to take each dose with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Patients received rociletinib in 21-day cycles and were treated until there was progression by RECIST v1.1, clinical tumor progression, or unacceptable toxicity, or other discontinuation criteria were met. Patients could opt to continue to receive treatment with rociletinib following radiographic progression as outlined in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of NSCLC with EGFR-TKIs if the patient provided consent, and the investigator and sponsor approved.
Period Title: Overall Study
Started [1] 38 19 209 245 95 6
Started Phase 1 [2] 38 19 18 17 13 6
Started Phase 2 0 0 191 228 82 0
Completed 0 0 0 0 0 0
Not Completed 38 19 209 245 95 6
Reason Not Completed
Progressive Disease             35             17             150             182             76             4
Adverse Event             2             1             29             40             13             2
Death             0             0             3             0             0             0
Withdrawal by Subject             1             0             13             11             3             0
Physician Decision             0             0             2             5             0             0
Other Reason             0             1             11             4             1             0
Lost to Follow-up             0             0             0             1             0             0
Protocol Deviation             0             0             0             2             0             0
Missing             0             0             1             0             2             0
[1]
Total
[2]
Upon completion of Cycle 1, Phase 1 pts could participate in an optional Treatment-extension Period
Arm/Group Title Rociletinib <900 mg BID FB Capsules Rociletinib 900 mg BID FB Capsules Rociletinib 500 mg BID HBr Tablets Rociletinib 625 mg BID HBr Tablets Rociletinib 750 mg BID HBr Tablets Rociletinib 1000 mg BID HBr Tablets Total
Hide Arm/Group Description Rociletinib free base (FB) dose <900 mg twice a day (BID). Rociletinib free base (FB) dose 900 mg twice a day (BID). Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID). Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID). Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID). Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID). Total of all reporting groups
Overall Number of Baseline Participants 38 19 209 245 95 6 612
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 19 participants 209 participants 245 participants 95 participants 6 participants 612 participants
60.1  (11.54) 58.9  (8.37) 63.6  (11.45) 62.5  (11.14) 61.5  (11.82) 65.2  (5.53) 62.5  (11.29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 19 participants 209 participants 245 participants 95 participants 6 participants 612 participants
Female
31
  81.6%
15
  78.9%
155
  74.2%
155
  63.3%
63
  66.3%
5
  83.3%
424
  69.3%
Male
7
  18.4%
4
  21.1%
54
  25.8%
90
  36.7%
32
  33.7%
1
  16.7%
188
  30.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 19 participants 209 participants 245 participants 95 participants 6 participants 612 participants
Hispanic or Latino
2
   5.3%
2
  10.5%
5
   2.4%
14
   5.7%
2
   2.1%
0
   0.0%
25
   4.1%
Not Hispanic or Latino
30
  78.9%
15
  78.9%
170
  81.3%
184
  75.1%
90
  94.7%
6
 100.0%
495
  80.9%
Unknown or Not Reported
6
  15.8%
2
  10.5%
34
  16.3%
47
  19.2%
3
   3.2%
0
   0.0%
92
  15.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 19 participants 209 participants 245 participants 95 participants 6 participants 612 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.4%
0
   0.0%
0
   0.0%
1
   0.2%
Asian
5
  13.2%
4
  21.1%
41
  19.6%
49
  20.0%
24
  25.3%
1
  16.7%
124
  20.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
4
   1.9%
3
   1.2%
0
   0.0%
0
   0.0%
7
   1.1%
Black or African American
0
   0.0%
0
   0.0%
7
   3.3%
8
   3.3%
2
   2.1%
0
   0.0%
17
   2.8%
White
27
  71.1%
13
  68.4%
122
  58.4%
137
  55.9%
64
  67.4%
5
  83.3%
368
  60.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.4%
0
   0.0%
0
   0.0%
1
   0.2%
Unknown or Not Reported
6
  15.8%
2
  10.5%
35
  16.7%
46
  18.8%
5
   5.3%
0
   0.0%
94
  15.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White Number Analyzed 38 participants 19 participants 209 participants 245 participants 95 participants 6 participants 612 participants
27
  71.1%
13
  68.4%
122
  58.4%
137
  55.9%
64
  67.4%
5
  83.3%
368
  60.1%
Black or African American Number Analyzed 38 participants 19 participants 209 participants 245 participants 95 participants 6 participants 612 participants
0
   0.0%
0
   0.0%
7
   3.3%
8
   3.3%
2
   2.1%
0
   0.0%
17
   2.8%
Asian Number Analyzed 38 participants 19 participants 209 participants 245 participants 95 participants 6 participants 612 participants
5
  13.2%
4
  21.1%
41
  19.6%
49
  20.0%
24
  25.3%
1
  16.7%
124
  20.3%
Other Number Analyzed 38 participants 19 participants 209 participants 245 participants 95 participants 6 participants 612 participants
6
  15.8%
2
  10.5%
39
  18.7%
51
  20.8%
5
   5.3%
0
   0.0%
103
  16.8%
Time Since Diagnosis of NSCLC (months)   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 38 participants 19 participants 208 participants 245 participants 95 participants 6 participants 611 participants
40.4  (29.2) 45.4  (31.94) 36.7  (25.81) 36.7  (31.41) 37.6  (29.97) 47.4  (27.03) 37.4  (29.17)
[1]
Measure Analysis Population Description: Data not available for one participant in the 500 mg BID Hbr treatment group.
T790M Status ( Determined by Central Lab)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 19 participants 209 participants 245 participants 95 participants 6 participants 612 participants
Negative
5
  13.2%
4
  21.1%
6
   2.9%
25
  10.2%
9
   9.5%
0
   0.0%
49
   8.0%
Positive
23
  60.5%
9
  47.4%
188
  90.0%
176
  71.8%
80
  84.2%
4
  66.7%
480
  78.4%
Unknown
10
  26.3%
6
  31.6%
4
   1.9%
1
   0.4%
1
   1.1%
2
  33.3%
24
   3.9%
Missing
0
   0.0%
0
   0.0%
11
   5.3%
43
  17.6%
5
   5.3%
0
   0.0%
59
   9.6%
History of CNS Metastases  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 19 participants 209 participants 245 participants 95 participants 6 participants 612 participants
20
  52.6%
7
  36.8%
86
  41.1%
107
  43.7%
44
  46.3%
3
  50.0%
267
  43.6%
Number of Previous Therapies  
Mean (Standard Deviation)
Unit of measure:  Therapies
Number Analyzed 38 participants 19 participants 209 participants 245 participants 95 participants 6 participants 612 participants
3.8  (1.65) 3.7  (1.66) 2.6  (1.74) 2.8  (1.91) 2.9  (2.11) 3.8  (2.04) 2.9  (1.88)
Number of Previous TKI Therapies  
Mean (Standard Deviation)
Unit of measure:  Therapies
Number Analyzed 38 participants 19 participants 209 participants 245 participants 95 participants 6 participants 612 participants
1.7  (0.77) 2.3  (1.48) 1.5  (0.87) 1.6  (0.77) 1.6  (0.86) 1.8  (0.75) 1.6  (0.86)
1.Primary Outcome
Title Percentage of T790M Positive Patients With Confirmed Response Per Investigator
Hide Description Percentage of patients with a T790M mutation (determined by central lab) with a best overall confirmed response of partial response (PR) or complete response (CR) recorded from the start of the treatment until disease progression or recurrence. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR),at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
Time Frame Cycle 1 Day 1 to End of Treatment, up to approximately 42 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat: All randomized patients who are confirmed by central lab to be T790M positive
Arm/Group Title Rociletinib <900 mg BID FB Capsules Rociletinib 900 mg BID FB Capsules Rociletinib 500 mg BID HBr Tablets Rociletinib 625 mg BID HBr Tablets Rociletinib 750 mg BID HBr Tablets Rociletinib 1000 mg BID HBr Tablets
Hide Arm/Group Description:
Rociletinib free base (FB) dose <900 mg twice a day (BID).
Rociletinib free base (FB) dose 900 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
Overall Number of Participants Analyzed 23 9 188 176 80 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3
  33.3%
54
  28.7%
72
  40.9%
23
  28.7%
3
  75.0%
2.Primary Outcome
Title Duration of Response (DOR) in T790M Positive Patients According to RECIST Version 1.1 as Determined by Investigator Assessment
Hide Description Duration of Response in patients with a T790M mutation (determined by central lab) with confirmed response per investigator. The DOR for complete response (CR) and partial response (PR) was measured from the date that any of these best responses is first recorded until the first date that progressive disease (PD) is objectively documented. For patients who continue treatment post-progression, the first date of progression was used for the analysis.
Time Frame Cycle 1 Day 1 to End of Treatment, up to approximately 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
The DOR was measured only in T790M positive patients with a Complete Response (CR) or Partial Response (PR). There were no responders in the Rociletinib <900 mg BID treatment group so DOR is not applicable and thus not reported.
Arm/Group Title Rociletinib 900 mg BID FB Capsules Rociletinib 500 mg BID HBr Tablets Rociletinib 625 mg BID HBr Tablets Rociletinib 750 mg BID HBr Tablets Rociletinib 1000 mg BID HBr Tablets
Hide Arm/Group Description:
Rociletinib free base (FB) dose 900 mg twice a day (BID)
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID)
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID)
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID)
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID)
Overall Number of Participants Analyzed 3 54 72 23 3
Median (95% Confidence Interval)
Unit of Measure: Days
329.0
(190.0 to 713.0)
275.0
(226.0 to 336.0)
274.0
(169.0 to 337.0)
217.0
(146.0 to 340.0)
428 [1] 
(NA to NA)
[1]
There are an insufficient number of participants with events.
3.Primary Outcome
Title Dose Limiting Toxicity (DLT) Incidence
Hide Description The number of Phase 1 patients who experienced dose limiting toxicities after one cycle (21 days) of study drug.
Time Frame Cycle 1 Day 1 to Cycle 1 Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The dose limiting toxicity (DLT) evaluable population includes all patients who have completed Cycle 1, and who were enrolled while the dose escalation (Phase 1) part of the study was ongoing.
Arm/Group Title Rociletinib <900 mg BID FB Capsules Rociletinib 900 mg BID FB Capsules Rociletinib 500 mg BID HBr Tablets Rociletinib 625 mg BID HBr Tablets Rociletinib 750 mg BID HBr Tablets Rociletinib 1000 mg BID HBr Tablets
Hide Arm/Group Description:
Rociletinib free base (FB) dose <900 mg twice a day (BID).
Rociletinib free base (FB) dose 900 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
Overall Number of Participants Analyzed 24 6 6 8 9 6
Measure Type: Count of Participants
Unit of Measure: Participants
1
   4.2%
1
  16.7%
1
  16.7%
2
  25.0%
1
  11.1%
1
  16.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rociletinib <900 mg BID FB Capsules, Rociletinib 900 mg BID FB Capsules, Rociletinib 500 mg BID HBr Tablets, Rociletinib 625 mg BID HBr Tablets, Rociletinib 750 mg BID HBr Tablets, Rociletinib 1000 mg BID HBr Tablets
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Other Statistical Analysis Since an MTD was never reached for any of the rociletinib FB or HBr formulations/doses, a 750 mg BID HBr starting dose was selected based on early efficacy data from Phase 1, and enrollment into Phase 2 was initiated at this dosage. As the Phase 1 efficacy data matured, the recommended dose was adjusted to 625 mg BID based on antitumor activity and safety evaluations.
4.Secondary Outcome
Title Overall Survival (OS) Determined by Investigator Assessment
Hide Description Overall survival was calculated as 1+ the number of days from the first dose of study drug to death due to any cause. Patients without a documented date of death were censored on the date the patient was last known to be alive.
Time Frame Cycle 1 Day 1 to date of death, assessed up to 42 months
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of patients analyzed contains centrally determined T790M positive patients only. There are 2 less patients in the <900 mg BID FB group, and 1 less patient in each of the 500, 625 and 750 mg BID dose groups because they were not followed for OS.
Arm/Group Title Rociletinib <900 mg BID FB Capsules Rociletinib 900 mg BID FB Capsules Rociletinib 500 mg BID HBr Tablets Rociletinib 625 mg BID HBr Tablets Rociletinib 750 mg BID HBr Tablets Rociletinib 1000 mg BID HBr Tablets
Hide Arm/Group Description:
Rociletinib free base (FB) dose <900 mg twice a day (BID)
Rociletinib free base (FB) dose 900 mg twice a day (BID)
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID)
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID)
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID)
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID)
Overall Number of Participants Analyzed 21 9 187 175 79 4
Median (95% Confidence Interval)
Unit of Measure: months
16.3
(6.3 to 17.9)
23.7 [1] 
(1.4 to NA)
18.5 [1] 
(13.0 to NA)
15.0
(12.5 to 17.3)
12.9
(9.9 to 17.7)
7.2 [1] 
(2.2 to NA)
[1]
There are an insufficient number of participants with events.
5.Secondary Outcome
Title Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by Investigator Review (invPFS)
Hide Description Progression-free survival was calculated as the number of days from the date of the first dose of study drug to the date of disease progression or death due to any cause + 1. Patients without a documented event of disease progression were censored on the date of their last adequate tumor assessment (i.e., radiologic assessment) or date of first dose of study drug if no tumor assessments have been performed. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Time Frame Cycle 1 Day 1 to End of Treatment, up to approximately 42 months
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of patients analyzed contains centrally determined T790M positive patients only. There are 2 less patients in the <900 mg BID FB group, and 1 less patient in each of the 500 and 625 mg BID dose groups because they were not followed for PFS.
Arm/Group Title Rociletinib <900 mg BID FB Capsules Rociletinib 900 mg BID FB Capsules Rociletinib 500 mg BID HBr Tablets Rociletinib 625 mg BID HBr Tablets Rociletinib 750 mg BID HBr Tablets Rociletinib 1000 mg BID HBr Tablets
Hide Arm/Group Description:
Rociletinib free base (FB) dose <900 mg twice a day (BID)
Rociletinib free base (FB) dose 900 mg twice a day (BID)
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID)
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID)
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID)
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID)
Overall Number of Participants Analyzed 21 9 187 175 80 4
Median (95% Confidence Interval)
Unit of Measure: months
2.6
(1.3 to 4.0)
10.4
(1.4 to 12.2)
5.7
(4.2 to 6.2)
5.2
(4.1 to 6.2)
4.3
(2.9 to 6.1)
7.2
(2.2 to 16.7)
6.Secondary Outcome
Title PK Profile of Rociletinib - Cmax
Hide Description Cmax = maximum concentration following administration of rociletinib
Time Frame Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameters were assessed in a subset of patients treated with rociletinib. For some parameters, the number analyzed at Day 1 and Day 15 differs from the overall number analyzed based on the number of evaluable samples collected at each time point.
Arm/Group Title Rociletinib 150 mg QD FB Capsules Rociletinib 200 mg QD FB Capsules Rociletinib 300 mg QD FB Capsules Rociletinib 450 mg QD FB Capsules Rociletinib 600 mg QD FB Capsules Rociletinib 900 mg QD FB Capsules Rociletinib 100 mg BID FB Capsules Rociletinib 300 mg BID FB Capsules Rociletinib 600 mg BID FB Capsules Rociletinib 900 mg BID FB Capsules Rociletinib 400 mg TID FB Capsules Rociletinib 500 mg BID HBr Tablets Rociletinib 625 mg BID HBr Tablets Rociletinib 750 mg BID HBr Tablets Rociletinib 1000 mg BID HBr Tablets
Hide Arm/Group Description:
Rociletinib free base (FB) dose 150 mg once a day (QD).
Rociletinib free base (FB) dose 200 mg once a day (QD).
Rociletinib free base (FB) dose 300 mg once a day (QD).
Rociletinib free base (FB) dose 450 mg once a day (QD).
Rociletinib free base (FB) dose 600 mg once a day (QD).
Rociletinib free base (FB) dose 900 mg once a day (QD).
Rociletinib free base (FB) dose 100 mg twice a day (BID).
Rociletinib free base (FB) dose 300 mg twice a day (BID).
Rociletinib free base (FB) dose 600 mg twice a day (BID).
Rociletinib free base (FB) dose 900 mg twice a day (BID).
Rociletinib free base (FB) dose 400 mg three times a day (TID).
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
Overall Number of Participants Analyzed 9 3 3 3 3 3 3 3 5 19 3 18 21 23 6
Mean (Standard Deviation)
Unit of Measure: ng/mL
Day 1 Cmax Number Analyzed 9 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 5 participants 19 participants 3 participants 18 participants 21 participants 23 participants 6 participants
537  (71) 533  (63) 1290  (1019) 1800  (1224) 969  (824) 2470  (1482) 574  (293) 706  (88) 1680  (1126) 1650  (809) 704  (352) 2800  (2128) 2980  (2235) 2570  (1850) 4250  (2678)
Day 15 Cmax Number Analyzed 8 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 5 participants 19 participants 3 participants 16 participants 16 participants 22 participants 5 participants
250  (188) 503  (377) 1760  (1056) 942  (857) 981  (343) 2200  (1100) 729  (576) 647  (304) 928  (95) 1510  (997) 1140  (274) 2330  (1375) 3070  (2272) 2100  (1029) 2510  (728)
7.Secondary Outcome
Title PK Profile of Rociletinib - Tmax
Hide Description Tmax = time to maximum concentration following administration of rociletinib
Time Frame Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameters were assessed in a subset of patients treated with rociletinib. For some parameters, the number analyzed at Day 1 and Day 15 differs from the overall number analyzed based on the number of evaluable samples collected at each time point.
Arm/Group Title Rociletinib 150 mg QD FB Capsules Rociletinib 200 mg QD FB Capsules Rociletinib 300 mg QD FB Capsules Rociletinib 450 mg QD FB Capsules Rociletinib 600 mg QD FB Capsules Rociletinib 900 mg QD FB Capsules Rociletinib 100 mg BID FB Capsules Rociletinib 300 mg BID FB Capsules Rociletinib 600 mg BID FB Capsules Rociletinib 900 mg BID FB Capsules Rociletinib 400 mg TID FB Capsules Rociletinib 500 mg BID HBr Tablets Rociletinib 625 mg BID HBr Tablets Rociletinib 750 mg BID HBr Tablets Rociletinib 1000 mg BID HBr Tablets
Hide Arm/Group Description:
Rociletinib free base (FB) dose 150 mg once a day (QD).
Rociletinib free base (FB) dose 200 mg once a day (QD).
Rociletinib free base (FB) dose 300 mg once a day (QD).
Rociletinib free base (FB) dose 450 mg once a day (QD).
Rociletinib free base (FB) dose 600 mg once a day (QD).
Rociletinib free base (FB) dose 900 mg once a day (QD).
Rociletinib free base (FB) dose 100 mg twice a day (BID).
Rociletinib free base (FB) dose 300 mg twice a day (BID).
Rociletinib free base (FB) dose 600 mg twice a day (BID).
Rociletinib free base (FB) dose 900 mg twice a day (BID).
Rociletinib free base (FB) dose 400 mg three times a day (TID).
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
Overall Number of Participants Analyzed 9 3 3 3 3 3 3 3 5 19 3 18 21 23 6
Median (Full Range)
Unit of Measure: Hours
Day 1 Tmax Number Analyzed 9 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 5 participants 19 participants 3 participants 18 participants 21 participants 23 participants 6 participants
1.5
(1 to 2.5)
2.5
(1 to 2.5)
2.5
(1.5 to 6)
1.5
(1.5 to 2.5)
2.0
(1.5 to 2.5)
2.5
(2.5 to 4)
2.5
(2.5 to 4)
4.0
(4 to 8)
4.0
(2.5 to 6)
4.0
(1 to 8)
2.5
(1 to 10)
1.5
(0.5 to 10)
2.5
(1 to 8)
2.5
(1 to 8)
3.25
(1 to 4)
Day 15 Tmax Number Analyzed 8 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 5 participants 19 participants 3 participants 16 participants 16 participants 22 participants 5 participants
2.0
(1 to 4)
1.5
(1.5 to 2.5)
2.5
(2.5 to 4)
1.5
(1.5 to 2.5)
2.5
(1.5 to 6)
4.0
(1.5 to 4)
2.5
(1.5 to 2.5)
1.5
(1 to 6)
2.5
(2.5 to 4)
4
(0 to 8)
10
(10 to 10)
2.5
(1 to 8)
2.5
(1 to 6)
2.5
(1 to 8)
1.5
(1 to 4)
8.Secondary Outcome
Title PK Profile of Rociletinib - AUC 0-24
Hide Description AUC 0-24 = area under the curve from 0 to 24 hours
Time Frame Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameters were assessed in a subset of patients treated with rociletinib. For some parameters, the number analyzed at Day 1 and Day 15 differs from the overall number analyzed based on the number of evaluable samples collected at each time point. AUC was not calculated for patients in the 400 mg TID treatment group.
Arm/Group Title Rociletinib 150 mg QD FB Capsules Rociletinib 200 mg QD FB Capsules Rociletinib 300 mg QD FB Capsules Rociletinib 450 mg QD FB Capsules Rociletinib 600 mg QD FB Capsules Rociletinib 900 mg QD FB Capsules Rociletinib 100 mg BID FB Capsules Rociletinib 300 mg BID FB Capsules Rociletinib 600 mg BID FB Capsules Rociletinib 900 mg BID FB Capsules Rociletinib 500 mg BID HBr Tablets Rociletinib 625 mg BID HBr Tablets Rociletinib 750 mg BID HBr Tablets Rociletinib 1000 mg BID HBr Tablets
Hide Arm/Group Description:
Rociletinib free base (FB) dose 150 mg once a day (QD).
Rociletinib free base (FB) dose 200 mg once a day (QD).
Rociletinib free base (FB) dose 300 mg once a day (QD).
Rociletinib free base (FB) dose 450 mg once a day (QD).
Rociletinib free base (FB) dose 600 mg once a day (QD).
Rociletinib free base (FB) dose 900 mg once a day (QD).
Rociletinib free base (FB) dose 100 mg twice a day (BID).
Rociletinib free base (FB) dose 300 mg twice a day (BID).
Rociletinib free base (FB) dose 600 mg twice a day (BID).
Rociletinib free base (FB) dose 900 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
Overall Number of Participants Analyzed 9 3 3 3 3 3 3 3 5 19 18 21 23 6
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
Day 1 AUC 0-24 Number Analyzed 9 participants 2 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 5 participants 18 participants 16 participants 20 participants 19 participants 6 participants
2900  (290) 5330  (5880) 8370  (6612) 8850  (6461) 5840  (3387) 13300  (6650) 5740  (2927) 8470  (1008) 20400  (12444) 16000  (8960) 26800  (13668) 33100  (26149) 30300  (16968) 50100  (35070)
Day 15 AUC 0-24 Number Analyzed 8 participants 2 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 5 participants 17 participants 15 participants 15 participants 20 participants 6 participants
1540  (970) 3510  (2620) 12100  (11616) 4490  (3817) 4800  (2256) 11500  (6555) 7100  (4189) 6080  (4560) 12100  (1404) 17500  (10675) 23700  (13035) 31700  (18386) 25800  (14190) 28200  (16638)
9.Secondary Outcome
Title PK Profile of Rociletinib - T 1/2
Hide Description T 1/2 = elimination half-life following administration of rociletinib
Time Frame Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameters were assessed in a subset of patients treated with rociletinib. For some parameters, the number analyzed at Day 1 and Day 15 differs from the overall number analyzed based on the number of evaluable samples collected at each time point. Elimination half-life was not calculated for patients in the 400 mg TID treatment group.
Arm/Group Title Rociletinib 150 mg QD FB Capsules Rociletinib 200 mg QD FB Capsules Rociletinib 300 mg QD FB Capsules Rociletinib 450 mg QD FB Capsules Rociletinib 600 mg QD FB Capsules Rociletinib 900 mg QD FB Capsules Rociletinib 100 mg BID FB Capsules Rociletinib 300 mg BID FB Capsules Rociletinib 600 mg BID FB Capsules Rociletinib 900 mg BID FB Capsules Rociletinib 500 mg BID HBr Tablets Rociletinib 625 mg BID HBr Tablets Rociletinib 750 mg BID HBr Tablets Rociletinib 1000 mg BID HBr Tablets
Hide Arm/Group Description:
Rociletinib free base (FB) dose 150 mg once a day (QD).
Rociletinib free base (FB) dose 200 mg once a day (QD).
Rociletinib free base (FB) dose 300 mg once a day (QD).
Rociletinib free base (FB) dose 450 mg once a day (QD).
Rociletinib free base (FB) dose 600 mg once a day (QD).
Rociletinib free base (FB) dose 900 mg once a day (QD).
Rociletinib free base (FB) dose 100 mg twice a day (BID).
Rociletinib free base (FB) dose 300 mg twice a day (BID).
Rociletinib free base (FB) dose 600 mg twice a day (BID).
Rociletinib free base (FB) dose 900 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
Overall Number of Participants Analyzed 9 3 3 3 3 3 3 3 5 19 18 21 23 6
Mean (Standard Deviation)
Unit of Measure: Hours
Day 1 T 1/2 Number Analyzed 9 participants 2 participants 3 participants 3 participants 3 participants 3 participants 3 participants 2 participants 4 participants 12 participants 15 participants 14 participants 18 participants 6 participants
4.8  (3.6) 3.9  (2.3) 4.6  (1.7) 3.7  (1.1) 4.4  (0.9) 3.5  (2.8) 3.0  (0.8) 3.5  (1.0) 3.6  (0.9) 2.8  (0.7) 2.7  (0.7) 3.5  (1.5) 3.1  (1.5) 3.4  (0.9)
Day 15 T 1/2 Number Analyzed 8 participants 2 participants 3 participants 3 participants 3 participants 3 participants 3 participants 2 participants 5 participants 12 participants 14 participants 13 participants 19 participants 5 participants
5.5  (3.1) 3.5  (1.3) 4.3  (1.2) 3.9  (2.5) 4.1  (2.2) 3.5  (.56) 3.1  (0.9) 2.9  (0.7) 4.7  (3.4) 2.7  (1.9) 3.0  (1.6) 3.2  (0.8) 3.6  (3.1) 3.9  (1.9)
10.Secondary Outcome
Title Food Effect on PK of Rociletinib - Cmax
Hide Description Cmax = maximum concentration following administration of rociletinib. The effect of food on rociletinib PK parameters was assessed over a 24-hour period in blood samples from a subset of 3 patients. These patients were given a single dose of rociletinib 150mg FB 1 week prior (Day -7) to the start of continuous daily dosing after fasting. On Day 1 of Cycle 1, patients consumed a high-fat, high-calorie breakfast at the study site prior to receiving rociletinib. On each day, patients underwent blood sampling for PK at the specified time points.
Time Frame Day -7 prior to Cycle 1 Day 1, or approximately 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of 3 patients treated with rociletinib 150 mg FB capsules
Arm/Group Title Cmax Fasting Cmax Fed
Hide Arm/Group Description:
Rociletinib 150 mg FB single dose given while fasting
Rociletinib 150 mg FB single dose given with a high-fat breakfast
Overall Number of Participants Analyzed 3 3
Mean (Standard Deviation)
Unit of Measure: ng/mL
727  (354) 1873  (2570)
11.Secondary Outcome
Title Food Effect on PK of Rociletinib - Tmax
Hide Description Tmax = time to maximum concentration following administration of rociletinib. The effect of food on rociletinib PK parameters was assessed over a 24-hour period in blood samples from a subset of 3 patients. These patients were given a single dose of rociletinib 150mg FB 1 week prior (Day -7) to the start of continuous daily dosing after fasting. On Day 1 of Cycle 1, patients consumed a high-fat, high-calorie breakfast at the study site prior to receiving rociletinib. On each day, patients underwent blood sampling for PK at the specified time points.
Time Frame Day -7 prior to Cycle 1 Day 1, or approximately 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of 3 patients treated with rociletinib 150 mg FB capsules
Arm/Group Title Tmax Fasting Tmax Fed
Hide Arm/Group Description:
Rociletinib 150 mg FB single dose given while fasting
Rociletinib 150 mg FB single dose given with a high-fat breakfast
Overall Number of Participants Analyzed 3 3
Median (Full Range)
Unit of Measure: Hours
1.5
(1.0 to 2.5)
4.8
(2.5 to 8.0)
12.Secondary Outcome
Title Food Effect on PK of Rociletinib - AUC 0-24
Hide Description AUC 0-24 = area under the curve from 0 to 24 hours. The effect of food on rociletinib PK parameters was assessed over a 24-hour period in blood samples from a subset of 3 patients. These patients were given a single dose of rociletinib 150mg FB 1 week prior (Day -7) to the start of continuous daily dosing after fasting. On Day 1 of Cycle 1, patients consumed a high-fat, high-calorie breakfast at the study site prior to receiving rociletinib. On each day, patients underwent blood sampling for PK at the specified time points.
Time Frame Day -7 prior to Cycle 1 Day 1, or approximately 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of 3 patients treated with rociletinib 150 mg FB capsules. AUC could not be determined for 1 patient in the Fed arm.
Arm/Group Title AUC 0-24 Fasting AUC 0-24 Fed
Hide Arm/Group Description:
Rociletinib 150 mg FB single dose given while fasting
Rociletinib 150 mg FB single dose given with a high-fat breakfast
Overall Number of Participants Analyzed 3 2
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
4780  (3625) 4455  (2256)
13.Secondary Outcome
Title Food Effect on PK of Rociletinib - C24
Hide Description C24 = rociletinib plasma concentration at 24 hours post the morning dose. The effect of food on rociletinib PK parameters was assessed over a 24-hour period in blood samples from a subset of 3 patients. These patients were given a single dose of rociletinib 150mg FB 1 week prior (Day -7) to the start of continuous daily dosing after fasting. On Day 1 of Cycle 1, patients consumed a high-fat, high-calorie breakfast at the study site prior to receiving rociletinib. On each day, patients underwent blood sampling for PK at the specified time points.
Time Frame Day -7 prior to Cycle 1 Day 1, or approximately 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of 3 patients treated with rociletinib 150 mg FB capsules
Arm/Group Title C24 Fasting C24 Fed
Hide Arm/Group Description:
Rociletinib 150 mg FB single dose given while fasting
Rociletinib 150 mg FB single dose given with a high-fat breakfast
Overall Number of Participants Analyzed 3 3
Mean (Standard Deviation)
Unit of Measure: ng/mL
21.3  (22) 46.5  (51)
14.Secondary Outcome
Title Food Effect on PK of Rociletinib - T 1/2
Hide Description T 1/2 = elimination half-life following administration of rociletinib. The effect of food on rociletinib PK parameters was assessed over a 24-hour period in blood samples from a subset of 3 patients. These patients were given a single dose of rociletinib 150mg FB 1 week prior (Day -7) to the start of continuous daily dosing after fasting. On Day 1 of Cycle 1, patients consumed a high-fat, high-calorie breakfast at the study site prior to receiving rociletinib. On each day, patients underwent blood sampling for PK at the specified time points.
Time Frame Day -7 prior to Cycle 1 Day 1, or approximately 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of 3 patients treated with rociletinib 150 mg FB capsules. Data did not allow the calculation of half-life with high fat mean in 2 patients.
Arm/Group Title T 1/2 Fasting T 1/2 Fed
Hide Arm/Group Description:
Rociletinib 150 mg FB single dose given while fasting
Rociletinib 150 mg FB single dose given with a high-fat breakfast
Overall Number of Participants Analyzed 3 1
Mean (Standard Deviation)
Unit of Measure: Hours
4.3  (1) 3.1 [1]   (NA)
[1]
Data for one patient only so standard deviation not applicable.
15.Secondary Outcome
Title QTcF Values Post Baseline by Daily Dose
Hide Description Frequency of QT interval prolongation by daily dose (corrected using Fridericia's method, QTcF). To evaluate the effects of rociletinib on the QT (interval from Q wave to T wave)/QTc (interval corrected for heart rate) interval, all patients underwent serial ECG monitoring at Baseline, on Cycle 1 Day 1, Cycle 1 Day 15, on Day 1 of all subsequent cycles, at the EOT Visit, and as clinically indicated. Worst post-baseline QTcF value was used to categorize each patient.
Time Frame Screening to End of Treatment, up to approximately 42 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population by daily dose
Arm/Group Title Rociletinib <900 mg BID FB Capsules Rociletinib 900 mg BID FB Capsules Rociletinib 500 mg BID HBr Tablets Rociletinib 625 mg BID HBr Tablets Rociletinib 750 mg BID HBr Tablets Rociletinib 1000 mg BID HBr Tablets
Hide Arm/Group Description:
Rociletinib free base (FB) dose <900 mg twice a day (BID).
Rociletinib free base (FB) dose 900 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
Overall Number of Participants Analyzed 38 19 209 245 95 6
Measure Type: Count of Participants
Unit of Measure: Participants
QTcF Post-Baseline <450 msec
34
  89.5%
10
  52.6%
93
  44.5%
99
  40.4%
35
  36.8%
2
  33.3%
QTcF Post-Baseline 450-480 msec
4
  10.5%
7
  36.8%
71
  34.0%
93
  38.0%
30
  31.6%
2
  33.3%
QTcF Post-Baseline 481-500 msec
0
   0.0%
1
   5.3%
23
  11.0%
24
   9.8%
11
  11.6%
2
  33.3%
QTcF Post-Baseline >=501 msec
0
   0.0%
1
   5.3%
22
  10.5%
29
  11.8%
19
  20.0%
0
   0.0%
16.Secondary Outcome
Title QTcF Value Change From Baseline
Hide Description QTcF value change from baseline by daily dose (corrected using Fridericia's method, QTcF). To evaluate the effects of rociletinib on the QT (interval from Q wave to T wave)/QTc (interval corrected for heart rate) interval, all patients underwent serial ECG monitoring at Baseline, on Cycle 1 Day 1, Cycle 1 Day 15, on Day 1 of all subsequent cycles, at the EOT Visit, and as clinically indicated. Worst post-baseline QTcF value was used to categorize each patient.
Time Frame Screening to End of Treatment, up to approximately 42 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population by daily dose
Arm/Group Title Rociletinib <900 mg BID FB Capsules Rociletinib 900 mg BID FB Capsules Rociletinib 500 mg BID HBr Tablets Rociletinib 625 mg BID HBr Tablets Rociletinib 750 mg BID HBr Tablets Rociletinib 1000 mg BID HBr Tablets
Hide Arm/Group Description:
Rociletinib free base (FB) dose <900 mg twice a day (BID).
Rociletinib free base (FB) dose 900 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
Overall Number of Participants Analyzed 38 19 209 245 95 6
Measure Type: Count of Participants
Unit of Measure: Participants
QTcF Change from Baseline <=30 msec
29
  76.3%
11
  57.9%
47
  22.5%
55
  22.4%
12
  12.6%
1
  16.7%
QTcF Change from Baseline 30-60 msec
9
  23.7%
8
  42.1%
104
  49.8%
101
  41.2%
39
  41.1%
3
  50.0%
QTcF Change from Baseline >60 msec
0
   0.0%
0
   0.0%
58
  27.8%
89
  36.3%
44
  46.3%
2
  33.3%
17.Secondary Outcome
Title Objective Response Rate (ORR), Duration of Response (DOR) and Progression-Free Survival (PFS) Per RECIST Version 1.1 as Determined by IRR
Hide Description Objective response rate (ORR), duration of response (DOR) and progression-free survival (PFS) per RECIST Version 1.1 as determined by independent radiology review (IRR)
Time Frame Cycle 1 Day 1 to End of Treatment / End of Follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Tumor scans were collected for independent evaluation, however ORR, DOR and PFS analyses were not performed by the central reader since the sponsor deemed not necessary following early study termination. Therefore, all IRR outcome measures were not collected and can not be reported.
Arm/Group Title Rociletinib 500 mg BID HBr Tablets Rociletinib 625 mg BID HBr Tablets
Hide Arm/Group Description:
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
Adverse Event Reporting Description If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
 
Arm/Group Title Rociletinib <900 mg BID FB Capsules Rociletinib 900 mg BID FB Capsules Rociletinib 500 mg BID HBr Tablets Rociletinib 625 mg BID HBr Tablets Rociletinib 750 mg BID HBr Tablets Rociletinib 1000 mg BID HBr Tablets
Hide Arm/Group Description Rociletinib free base (FB) dose <900 mg twice a day (BID). Rociletinib free base (FB) dose 900 mg twice a day (BID). Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID). Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID). Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID). Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
All-Cause Mortality
Rociletinib <900 mg BID FB Capsules Rociletinib 900 mg BID FB Capsules Rociletinib 500 mg BID HBr Tablets Rociletinib 625 mg BID HBr Tablets Rociletinib 750 mg BID HBr Tablets Rociletinib 1000 mg BID HBr Tablets
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/38 (10.53%)   4/19 (21.05%)   31/209 (14.83%)   40/245 (16.33%)   19/95 (20.00%)   3/6 (50.00%) 
Hide Serious Adverse Events
Rociletinib <900 mg BID FB Capsules Rociletinib 900 mg BID FB Capsules Rociletinib 500 mg BID HBr Tablets Rociletinib 625 mg BID HBr Tablets Rociletinib 750 mg BID HBr Tablets Rociletinib 1000 mg BID HBr Tablets
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/38 (36.84%)   8/19 (42.11%)   106/209 (50.72%)   138/245 (56.33%)   54/95 (56.84%)   5/6 (83.33%) 
Blood and lymphatic system disorders             
Anaemia † 1  0/38 (0.00%)  0/19 (0.00%)  4/209 (1.91%)  2/245 (0.82%)  2/95 (2.11%)  0/6 (0.00%) 
Lymphadenopathy † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Cardiac disorders             
Acute myocardial infarction † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Atrial fibrillation † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  1/245 (0.41%)  2/95 (2.11%)  0/6 (0.00%) 
Atrial tachycardia † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Atrioventricular block complete † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Bradycardia † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  0/245 (0.00%)  1/95 (1.05%)  0/6 (0.00%) 
Cardiac arrest † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Cardiac failure congestive † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Palpitations † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  0/245 (0.00%)  1/95 (1.05%)  0/6 (0.00%) 
Pericardial effusion † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  3/245 (1.22%)  1/95 (1.05%)  0/6 (0.00%) 
Pericarditis † 1  1/38 (2.63%)  0/19 (0.00%)  0/209 (0.00%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Sinus tachycardia † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Supraventricular tachycardia † 1  0/38 (0.00%)  0/19 (0.00%)  2/209 (0.96%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Torsade de pointes † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  2/245 (0.82%)  0/95 (0.00%)  0/6 (0.00%) 
Ventricular tachyarrhythmia † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Ear and labyrinth disorders             
Vertigo † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Endocrine disorders             
Adrenal insufficiency † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Inappropriate antidiuretic hormone secretion † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  0/245 (0.00%)  1/95 (1.05%)  0/6 (0.00%) 
Eye disorders             
Cataract † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  4/245 (1.63%)  3/95 (3.16%)  1/6 (16.67%) 
Gastrointestinal disorders             
Abdominal pain † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  7/245 (2.86%)  1/95 (1.05%)  0/6 (0.00%) 
Abdominal pain upper † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Ascites † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Colitis † 1  0/38 (0.00%)  0/19 (0.00%)  2/209 (0.96%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Constipation † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  3/245 (1.22%)  1/95 (1.05%)  0/6 (0.00%) 
Diarrhoea † 1  1/38 (2.63%)  1/19 (5.26%)  2/209 (0.96%)  5/245 (2.04%)  1/95 (1.05%)  0/6 (0.00%) 
Gastrointestinal haemorrhage † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  2/245 (0.82%)  2/95 (2.11%)  0/6 (0.00%) 
Gastrooesophageal reflux disease † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  0/245 (0.00%)  1/95 (1.05%)  0/6 (0.00%) 
Ileus † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Intestinal dilatation † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  0/245 (0.00%)  1/95 (1.05%)  0/6 (0.00%) 
Intestinal Obstruction † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  0/245 (0.00%)  1/95 (1.05%)  0/6 (0.00%) 
Large intestinal obstruction † 1  0/38 (0.00%)  0/19 (0.00%)  2/209 (0.96%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Mallory-Weiss syndrome † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Melaena † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Nausea † 1  1/38 (2.63%)  0/19 (0.00%)  5/209 (2.39%)  6/245 (2.45%)  1/95 (1.05%)  0/6 (0.00%) 
Oesophagitis † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Pancreatitis † 1  0/38 (0.00%)  0/19 (0.00%)  5/209 (2.39%)  4/245 (1.63%)  1/95 (1.05%)  1/6 (16.67%) 
Pancreatitis acute † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Rectal haemorrhage † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Small intestinal obstruction † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Small intestinal perforation † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Subileus † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Upper gastrointestinal haemorrhage † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Vomiting † 1  1/38 (2.63%)  0/19 (0.00%)  7/209 (3.35%)  7/245 (2.86%)  1/95 (1.05%)  0/6 (0.00%) 
General disorders             
Asthenia † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  2/245 (0.82%)  2/95 (2.11%)  0/6 (0.00%) 
Fatigue † 1  0/38 (0.00%)  0/19 (0.00%)  2/209 (0.96%)  1/245 (0.41%)  0/95 (0.00%)  1/6 (16.67%) 
General physical health deterioration † 1  0/38 (0.00%)  0/19 (0.00%)  2/209 (0.96%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Non-cardiac chest pain † 1  0/38 (0.00%)  0/19 (0.00%)  2/209 (0.96%)  3/245 (1.22%)  0/95 (0.00%)  0/6 (0.00%) 
Oedema peripheral † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Pain † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  1/95 (1.05%)  0/6 (0.00%) 
Pyrexia † 1  0/38 (0.00%)  0/19 (0.00%)  4/209 (1.91%)  3/245 (1.22%)  1/95 (1.05%)  0/6 (0.00%) 
Sudden death † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  1/95 (1.05%)  0/6 (0.00%) 
Hepatobiliary disorders             
Bile duct obstruction † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Bile duct stone † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Cholecystitis † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  3/245 (1.22%)  1/95 (1.05%)  0/6 (0.00%) 
Cholecystitis acute † 1  0/38 (0.00%)  0/19 (0.00%)  2/209 (0.96%)  2/245 (0.82%)  0/95 (0.00%)  0/6 (0.00%) 
Cholelithiasis † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  1/245 (0.41%)  1/95 (1.05%)  0/6 (0.00%) 
Hepatic pain † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Liver injury † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  0/245 (0.00%)  1/95 (1.05%)  0/6 (0.00%) 
Immune system disorders             
Drug hypersensitivity † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Hypersensitivity † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Infections and infestations             
Arthritis bacterial † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Bacteraemia † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Bronchitis † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Cellulitis † 1  0/38 (0.00%)  0/19 (0.00%)  2/209 (0.96%)  0/245 (0.00%)  1/95 (1.05%)  0/6 (0.00%) 
Clostridium difficile colitis † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Clostridium difficile infection † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  2/245 (0.82%)  0/95 (0.00%)  1/6 (16.67%) 
Device related infection † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Endocarditis † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Gastroenteritis † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  0/245 (0.00%)  1/95 (1.05%)  0/6 (0.00%) 
Hepatic infection † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Influenza † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  2/245 (0.82%)  0/95 (0.00%)  0/6 (0.00%) 
Liver abscess † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Lung infection † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Pneumonia † 1  2/38 (5.26%)  0/19 (0.00%)  7/209 (3.35%)  10/245 (4.08%)  7/95 (7.37%)  2/6 (33.33%) 
Pneumonia bacterial † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Pneumonia influenzal † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Postoperative wound infection † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Pyelonephritis † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  2/245 (0.82%)  0/95 (0.00%)  0/6 (0.00%) 
Sepsis † 1  1/38 (2.63%)  0/19 (0.00%)  4/209 (1.91%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Septic shock † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Serratia bacteraemia † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  0/245 (0.00%)  1/95 (1.05%)  0/6 (0.00%) 
Staphylococcal bacteraemia † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  0/245 (0.00%)  1/95 (1.05%)  0/6 (0.00%) 
Urinary tract infection † 1  0/38 (0.00%)  0/19 (0.00%)  3/209 (1.44%)  3/245 (1.22%)  1/95 (1.05%)  0/6 (0.00%) 
Urosepsis † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  3/245 (1.22%)  0/95 (0.00%)  0/6 (0.00%) 
Injury, poisoning and procedural complications             
Fall † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Femoral neck fracture † 1  0/38 (0.00%)  1/19 (5.26%)  0/209 (0.00%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Hip fracture † 1  0/38 (0.00%)  1/19 (5.26%)  0/209 (0.00%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Jaw fracture † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Radiation necrosis † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  0/245 (0.00%)  1/95 (1.05%)  0/6 (0.00%) 
Radiation pneumonitis † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Rib fracture † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Subcutaneous haematoma † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Subdural haemorrhage † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Investigations             
Blood bilirubin increased † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Blood creatinine increased † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Electrocardiogram QT prolonged † 1  0/38 (0.00%)  0/19 (0.00%)  2/209 (0.96%)  2/245 (0.82%)  1/95 (1.05%)  0/6 (0.00%) 
Electrocardiogram T wave inversion † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  0/245 (0.00%)  1/95 (1.05%)  0/6 (0.00%) 
General physical condition abnormal † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Lipase increased † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Transaminases increased † 1  0/38 (0.00%)  1/19 (5.26%)  1/209 (0.48%)  1/245 (0.41%)  0/95 (0.00%)  1/6 (16.67%) 
Troponin increased † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Metabolism and nutrition disorders             
Decreased appetite † 1  0/38 (0.00%)  1/19 (5.26%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Dehydration † 1  0/38 (0.00%)  0/19 (0.00%)  2/209 (0.96%)  7/245 (2.86%)  1/95 (1.05%)  0/6 (0.00%) 
Diabetic ketoacidosis † 1  0/38 (0.00%)  0/19 (0.00%)  4/209 (1.91%)  3/245 (1.22%)  0/95 (0.00%)  0/6 (0.00%) 
Failure to thrive † 1  0/38 (0.00%)  0/19 (0.00%)  2/209 (0.96%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Fluid overload † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Glucose tolerance impaired † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Hypercalcaemia † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Hyperglycaemia † 1  1/38 (2.63%)  0/19 (0.00%)  21/209 (10.05%)  19/245 (7.76%)  7/95 (7.37%)  2/6 (33.33%) 
Hypoglycaemia † 1  1/38 (2.63%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Hypokalaemia † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  0/245 (0.00%)  2/95 (2.11%)  0/6 (0.00%) 
Hyponatraemia † 1  0/38 (0.00%)  0/19 (0.00%)  5/209 (2.39%)  4/245 (1.63%)  1/95 (1.05%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders             
Arthralgia † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  2/245 (0.82%)  0/95 (0.00%)  0/6 (0.00%) 
Back pain † 1  1/38 (2.63%)  0/19 (0.00%)  2/209 (0.96%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Bursitis † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Chondrocalcinosis pyrophosphate † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Muscular weakness † 1  0/38 (0.00%)  0/19 (0.00%)  2/209 (0.96%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Musculoskeletal chest pain † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  3/245 (1.22%)  1/95 (1.05%)  0/6 (0.00%) 
Pain in extremity † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Pathological fracture † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  1/95 (1.05%)  0/6 (0.00%) 
Spinal pain † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Basal cell carcinoma † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Cancer pain † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Malignant neoplasm progression † 1  8/38 (21.05%)  5/19 (26.32%)  25/209 (11.96%)  37/245 (15.10%)  21/95 (22.11%)  1/6 (16.67%) 
Malignant pleural infusion † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  2/245 (0.82%)  0/95 (0.00%)  0/6 (0.00%) 
Metastases to central nervous system † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Metastases to skin † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Neoplasm malignant † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Transitional cell carcinoma † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  0/245 (0.00%)  1/95 (1.05%)  0/6 (0.00%) 
Nervous system disorders             
Basilar artery thrombosis † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Brain oedema † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Cerebrovascular accident † 1  0/38 (0.00%)  0/19 (0.00%)  3/209 (1.44%)  0/245 (0.00%)  1/95 (1.05%)  0/6 (0.00%) 
Coma † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  0/245 (0.00%)  1/95 (1.05%)  0/6 (0.00%) 
Disturbance in attention † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Dizziness † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  2/245 (0.82%)  0/95 (0.00%)  0/6 (0.00%) 
Haemorrhage intracranial † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Headache † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  2/245 (0.82%)  3/95 (3.16%)  0/6 (0.00%) 
Presyncope † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Seizure † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  1/245 (0.41%)  3/95 (3.16%)  0/6 (0.00%) 
Spinal cord oedema † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Status epilepticus † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Syncope † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Transient ischaemic attack † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  2/245 (0.82%)  0/95 (0.00%)  0/6 (0.00%) 
Psychiatric disorders             
Anxiety † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Confusional state † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Hallucination † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Mental status changes † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  0/245 (0.00%)  2/95 (2.11%)  0/6 (0.00%) 
Renal and urinary disorders             
Acute kidney injury † 1  0/38 (0.00%)  0/19 (0.00%)  2/209 (0.96%)  1/245 (0.41%)  1/95 (1.05%)  0/6 (0.00%) 
Haematuria † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  2/245 (0.82%)  0/95 (0.00%)  0/6 (0.00%) 
Nephrolithiasis † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Renal failure † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Reproductive system and breast disorders             
Pelvic pain † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Vaginal haemorrhage † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Acute respiratory distress syndrome † 1  0/38 (0.00%)  0/19 (0.00%)  2/209 (0.96%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Aspiration † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Cough † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Dyspnoea † 1  0/38 (0.00%)  0/19 (0.00%)  8/209 (3.83%)  10/245 (4.08%)  0/95 (0.00%)  0/6 (0.00%) 
Dyspnoea exertional † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Epistaxis † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Haemoptysis † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  2/245 (0.82%)  0/95 (0.00%)  0/6 (0.00%) 
Hypoxia † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  2/245 (0.82%)  1/95 (1.05%)  0/6 (0.00%) 
Interstitial lung disease † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Lung disorder † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Pleural effusion † 1  0/38 (0.00%)  0/19 (0.00%)  2/209 (0.96%)  5/245 (2.04%)  2/95 (2.11%)  0/6 (0.00%) 
Pleuritic pain † 1  1/38 (2.63%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Pneumonia aspiration † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  2/245 (0.82%)  0/95 (0.00%)  0/6 (0.00%) 
Pneumonitis † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  2/245 (0.82%)  2/95 (2.11%)  0/6 (0.00%) 
Pneumothorax † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  4/245 (1.63%)  1/95 (1.05%)  0/6 (0.00%) 
Pulmonary embolism † 1  0/38 (0.00%)  0/19 (0.00%)  3/209 (1.44%)  5/245 (2.04%)  1/95 (1.05%)  0/6 (0.00%) 
Pulmonary fibrosis † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Pulmonary haemorrhage † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  2/245 (0.82%)  0/95 (0.00%)  0/6 (0.00%) 
Pulmonary hypertension † 1  0/38 (0.00%)  1/19 (5.26%)  0/209 (0.00%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Respiratory distress † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Respiratory failure † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Vascular disorders             
Deep vein thrombosis † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  3/245 (1.22%)  0/95 (0.00%)  0/6 (0.00%) 
Hypotension † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Subgaleal haematoma † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Venous thrombosis † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
1
Term from vocabulary, MedDRA (18.0)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rociletinib <900 mg BID FB Capsules Rociletinib 900 mg BID FB Capsules Rociletinib 500 mg BID HBr Tablets Rociletinib 625 mg BID HBr Tablets Rociletinib 750 mg BID HBr Tablets Rociletinib 1000 mg BID HBr Tablets
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   37/38 (97.37%)   19/19 (100.00%)   208/209 (99.52%)   244/245 (99.59%)   95/95 (100.00%)   6/6 (100.00%) 
Blood and lymphatic system disorders             
Anaemia † 1  5/38 (13.16%)  3/19 (15.79%)  47/209 (22.49%)  74/245 (30.20%)  19/95 (20.00%)  1/6 (16.67%) 
Increased tendency to bruise † 1  0/38 (0.00%)  2/19 (10.53%)  1/209 (0.48%)  0/245 (0.00%)  1/95 (1.05%)  0/6 (0.00%) 
Leukocytosis † 1  2/38 (5.26%)  0/19 (0.00%)  3/209 (1.44%)  3/245 (1.22%)  0/95 (0.00%)  0/6 (0.00%) 
Leukopenia † 1  1/38 (2.63%)  0/19 (0.00%)  8/209 (3.83%)  8/245 (3.27%)  6/95 (6.32%)  0/6 (0.00%) 
Lymphopenia † 1  0/38 (0.00%)  1/19 (5.26%)  9/209 (4.31%)  9/245 (3.67%)  0/95 (0.00%)  0/6 (0.00%) 
Neutropenia † 1  1/38 (2.63%)  0/19 (0.00%)  10/209 (4.78%)  11/245 (4.49%)  7/95 (7.37%)  0/6 (0.00%) 
Thrombocytopenia † 1  3/38 (7.89%)  3/19 (15.79%)  21/209 (10.05%)  19/245 (7.76%)  17/95 (17.89%)  0/6 (0.00%) 
Cardiac disorders             
Sinus tachycardia † 1  1/38 (2.63%)  1/19 (5.26%)  10/209 (4.78%)  1/245 (0.41%)  2/95 (2.11%)  0/6 (0.00%) 
Ear and labyrinth disorders             
Deafness unilateral † 1  0/38 (0.00%)  1/19 (5.26%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Dysacusis † 1  0/38 (0.00%)  1/19 (5.26%)  0/209 (0.00%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Eye disorders             
Cataract † 1  0/38 (0.00%)  0/19 (0.00%)  16/209 (7.66%)  29/245 (11.84%)  17/95 (17.89%)  2/6 (33.33%) 
Diplopia † 1  0/38 (0.00%)  1/19 (5.26%)  2/209 (0.96%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Dry eye † 1  1/38 (2.63%)  1/19 (5.26%)  4/209 (1.91%)  9/245 (3.67%)  0/95 (0.00%)  0/6 (0.00%) 
Lacrimation increased † 1  0/38 (0.00%)  1/19 (5.26%)  0/209 (0.00%)  2/245 (0.82%)  0/95 (0.00%)  0/6 (0.00%) 
Vision blurred † 1  1/38 (2.63%)  1/19 (5.26%)  13/209 (6.22%)  18/245 (7.35%)  13/95 (13.68%)  0/6 (0.00%) 
Visual acuity reduced † 1  1/38 (2.63%)  1/19 (5.26%)  4/209 (1.91%)  2/245 (0.82%)  0/95 (0.00%)  0/6 (0.00%) 
Visual impairment † 1  0/38 (0.00%)  0/19 (0.00%)  5/209 (2.39%)  5/245 (2.04%)  3/95 (3.16%)  1/6 (16.67%) 
Vitreous floaters † 1  0/38 (0.00%)  1/19 (5.26%)  3/209 (1.44%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders             
Abdominal distension † 1  0/38 (0.00%)  1/19 (5.26%)  8/209 (3.83%)  8/245 (3.27%)  3/95 (3.16%)  0/6 (0.00%) 
Abdominal pain † 1  3/38 (7.89%)  4/19 (21.05%)  25/209 (11.96%)  39/245 (15.92%)  17/95 (17.89%)  0/6 (0.00%) 
Abdominal pain upper † 1  2/38 (5.26%)  0/19 (0.00%)  15/209 (7.18%)  18/245 (7.35%)  11/95 (11.58%)  2/6 (33.33%) 
Constipation † 1  9/38 (23.68%)  2/19 (10.53%)  42/209 (20.10%)  94/245 (38.37%)  26/95 (27.37%)  2/6 (33.33%) 
Diarrhoea † 1  8/38 (21.05%)  11/19 (57.89%)  121/209 (57.89%)  146/245 (59.59%)  54/95 (56.84%)  3/6 (50.00%) 
Dry mouth † 1  2/38 (5.26%)  0/19 (0.00%)  26/209 (12.44%)  22/245 (8.98%)  16/95 (16.84%)  0/6 (0.00%) 
Dyspepsia † 1  2/38 (5.26%)  2/19 (10.53%)  7/209 (3.35%)  6/245 (2.45%)  5/95 (5.26%)  1/6 (16.67%) 
Flatulence † 1  0/38 (0.00%)  1/19 (5.26%)  3/209 (1.44%)  3/245 (1.22%)  2/95 (2.11%)  0/6 (0.00%) 
Gastrooesophageal reflux disease † 1  0/38 (0.00%)  2/19 (10.53%)  22/209 (10.53%)  26/245 (10.61%)  12/95 (12.63%)  0/6 (0.00%) 
Gingival bleeding † 1  0/38 (0.00%)  1/19 (5.26%)  2/209 (0.96%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Ileus † 1  0/38 (0.00%)  2/19 (10.53%)  1/209 (0.48%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Mouth ulceration † 1  3/38 (7.89%)  0/19 (0.00%)  1/209 (0.48%)  3/245 (1.22%)  0/95 (0.00%)  0/6 (0.00%) 
Nausea † 1  14/38 (36.84%)  11/19 (57.89%)  95/209 (45.45%)  138/245 (56.33%)  51/95 (53.68%)  3/6 (50.00%) 
Pancreatitis † 1  0/38 (0.00%)  0/19 (0.00%)  5/209 (2.39%)  5/245 (2.04%)  1/95 (1.05%)  1/6 (16.67%) 
Retching † 1  0/38 (0.00%)  1/19 (5.26%)  3/209 (1.44%)  0/245 (0.00%)  1/95 (1.05%)  0/6 (0.00%) 
Toothache † 1  2/38 (5.26%)  0/19 (0.00%)  1/209 (0.48%)  2/245 (0.82%)  2/95 (2.11%)  0/6 (0.00%) 
Vomiting † 1  9/38 (23.68%)  6/19 (31.58%)  65/209 (31.10%)  82/245 (33.47%)  32/95 (33.68%)  2/6 (33.33%) 
General disorders             
Asthenia † 1  6/38 (15.79%)  1/19 (5.26%)  28/209 (13.40%)  34/245 (13.88%)  17/95 (17.89%)  1/6 (16.67%) 
Catheter site pain † 1  0/38 (0.00%)  0/19 (0.00%)  2/209 (0.96%)  3/245 (1.22%)  0/95 (0.00%)  1/6 (16.67%) 
Chills † 1  1/38 (2.63%)  1/19 (5.26%)  6/209 (2.87%)  9/245 (3.67%)  1/95 (1.05%)  0/6 (0.00%) 
Face oedema † 1  0/38 (0.00%)  1/19 (5.26%)  1/209 (0.48%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Fatigue † 1  9/38 (23.68%)  8/19 (42.11%)  109/209 (52.15%)  124/245 (50.61%)  47/95 (49.47%)  3/6 (50.00%) 
Feeling abnormal † 1  0/38 (0.00%)  1/19 (5.26%)  1/209 (0.48%)  0/245 (0.00%)  1/95 (1.05%)  0/6 (0.00%) 
Feeling cold † 1  1/38 (2.63%)  0/19 (0.00%)  2/209 (0.96%)  0/245 (0.00%)  1/95 (1.05%)  1/6 (16.67%) 
Gait disturbance † 1  0/38 (0.00%)  3/19 (15.79%)  8/209 (3.83%)  10/245 (4.08%)  1/95 (1.05%)  0/6 (0.00%) 
Influenza like illness † 1  1/38 (2.63%)  1/19 (5.26%)  5/209 (2.39%)  1/245 (0.41%)  1/95 (1.05%)  0/6 (0.00%) 
Malaise † 1  0/38 (0.00%)  1/19 (5.26%)  5/209 (2.39%)  3/245 (1.22%)  2/95 (2.11%)  0/6 (0.00%) 
Non-cardiac chest pain † 1  3/38 (7.89%)  1/19 (5.26%)  9/209 (4.31%)  18/245 (7.35%)  4/95 (4.21%)  0/6 (0.00%) 
Oedema peripheral † 1  4/38 (10.53%)  1/19 (5.26%)  40/209 (19.14%)  31/245 (12.65%)  14/95 (14.74%)  0/6 (0.00%) 
Pain † 1  1/38 (2.63%)  1/19 (5.26%)  7/209 (3.35%)  8/245 (3.27%)  6/95 (6.32%)  0/6 (0.00%) 
Pyrexia † 1  4/38 (10.53%)  2/19 (10.53%)  19/209 (9.09%)  27/245 (11.02%)  7/95 (7.37%)  0/6 (0.00%) 
Temperature intolerance † 1  0/38 (0.00%)  1/19 (5.26%)  2/209 (0.96%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Hepatobiliary disorders             
Hyperbilirubinaemia † 1  2/38 (5.26%)  1/19 (5.26%)  6/209 (2.87%)  6/245 (2.45%)  5/95 (5.26%)  0/6 (0.00%) 
Jaundice † 1  0/38 (0.00%)  1/19 (5.26%)  0/209 (0.00%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Immune system disorders             
Seasonal allergy † 1  2/38 (5.26%)  0/19 (0.00%)  2/209 (0.96%)  1/245 (0.41%)  3/95 (3.16%)  0/6 (0.00%) 
Infections and infestations             
Bacterial disease carrier † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  0/245 (0.00%)  0/95 (0.00%)  1/6 (16.67%) 
Candida infection † 1  0/38 (0.00%)  1/19 (5.26%)  0/209 (0.00%)  5/245 (2.04%)  1/95 (1.05%)  0/6 (0.00%) 
Clostridium difficile infection † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  4/245 (1.63%)  0/95 (0.00%)  1/6 (16.67%) 
Cystitis † 1  0/38 (0.00%)  1/19 (5.26%)  3/209 (1.44%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Eye infection † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  0/245 (0.00%)  1/95 (1.05%)  1/6 (16.67%) 
Folliculitis † 1  0/38 (0.00%)  0/19 (0.00%)  2/209 (0.96%)  0/245 (0.00%)  0/95 (0.00%)  1/6 (16.67%) 
Nasopharyngitis † 1  1/38 (2.63%)  1/19 (5.26%)  6/209 (2.87%)  9/245 (3.67%)  0/95 (0.00%)  0/6 (0.00%) 
Pneumonia † 1  2/38 (5.26%)  1/19 (5.26%)  12/209 (5.74%)  15/245 (6.12%)  11/95 (11.58%)  2/6 (33.33%) 
Rhinitis † 1  0/38 (0.00%)  2/19 (10.53%)  1/209 (0.48%)  1/245 (0.41%)  1/95 (1.05%)  0/6 (0.00%) 
Sinusitis † 1  0/38 (0.00%)  1/19 (5.26%)  6/209 (2.87%)  9/245 (3.67%)  1/95 (1.05%)  0/6 (0.00%) 
Tooth infection † 1  0/38 (0.00%)  1/19 (5.26%)  2/209 (0.96%)  6/245 (2.45%)  1/95 (1.05%)  0/6 (0.00%) 
Upper respiratory tract infection † 1  3/38 (7.89%)  2/19 (10.53%)  23/209 (11.00%)  16/245 (6.53%)  14/95 (14.74%)  1/6 (16.67%) 
Urinary tract infection † 1  1/38 (2.63%)  1/19 (5.26%)  27/209 (12.92%)  25/245 (10.20%)  18/95 (18.95%)  0/6 (0.00%) 
Viral upper respiratory tract infection † 1  0/38 (0.00%)  1/19 (5.26%)  1/209 (0.48%)  1/245 (0.41%)  2/95 (2.11%)  0/6 (0.00%) 
Injury, poisoning and procedural complications             
Contusion † 1  0/38 (0.00%)  3/19 (15.79%)  14/209 (6.70%)  14/245 (5.71%)  4/95 (4.21%)  0/6 (0.00%) 
Fall † 1  0/38 (0.00%)  2/19 (10.53%)  9/209 (4.31%)  8/245 (3.27%)  4/95 (4.21%)  0/6 (0.00%) 
Femoral neck fracture † 1  0/38 (0.00%)  1/19 (5.26%)  0/209 (0.00%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Hip fracture † 1  0/38 (0.00%)  1/19 (5.26%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Investigations             
Alanine aminotransferase increased † 1  3/38 (7.89%)  3/19 (15.79%)  19/209 (9.09%)  26/245 (10.61%)  8/95 (8.42%)  0/6 (0.00%) 
Amylase increased † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  2/245 (0.82%)  0/95 (0.00%)  1/6 (16.67%) 
Aspartate aminotransferase increased † 1  4/38 (10.53%)  4/19 (21.05%)  21/209 (10.05%)  26/245 (10.61%)  10/95 (10.53%)  0/6 (0.00%) 
Blood alkaline phosphatase increased † 1  4/38 (10.53%)  1/19 (5.26%)  13/209 (6.22%)  16/245 (6.53%)  7/95 (7.37%)  1/6 (16.67%) 
Blood bilirubin increased † 1  0/38 (0.00%)  4/19 (21.05%)  16/209 (7.66%)  15/245 (6.12%)  13/95 (13.68%)  1/6 (16.67%) 
Blood creatinine increased † 1  0/38 (0.00%)  2/19 (10.53%)  13/209 (6.22%)  20/245 (8.16%)  7/95 (7.37%)  1/6 (16.67%) 
Blood glucose increased † 1  1/38 (2.63%)  1/19 (5.26%)  4/209 (1.91%)  9/245 (3.67%)  7/95 (7.37%)  2/6 (33.33%) 
Blood phosphorus decreased † 1  0/38 (0.00%)  0/19 (0.00%)  2/209 (0.96%)  0/245 (0.00%)  0/95 (0.00%)  1/6 (16.67%) 
Blood urine present † 1  0/38 (0.00%)  1/19 (5.26%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Electrocardiogram QT prolonged † 1  0/38 (0.00%)  3/19 (15.79%)  61/209 (29.19%)  77/245 (31.43%)  33/95 (34.74%)  3/6 (50.00%) 
Electrocardiogram T wave abnormal † 1  0/38 (0.00%)  1/19 (5.26%)  0/209 (0.00%)  0/245 (0.00%)  1/95 (1.05%)  0/6 (0.00%) 
Glycosylated haemoglobin increased † 1  0/38 (0.00%)  1/19 (5.26%)  2/209 (0.96%)  12/245 (4.90%)  2/95 (2.11%)  1/6 (16.67%) 
Insulin C-peptide increased † 1  0/38 (0.00%)  1/19 (5.26%)  2/209 (0.96%)  11/245 (4.49%)  5/95 (5.26%)  0/6 (0.00%) 
Lipase increased † 1  0/38 (0.00%)  0/19 (0.00%)  3/209 (1.44%)  2/245 (0.82%)  1/95 (1.05%)  1/6 (16.67%) 
Lymphocyte count decreased † 1  0/38 (0.00%)  0/19 (0.00%)  12/209 (5.74%)  8/245 (3.27%)  2/95 (2.11%)  0/6 (0.00%) 
Neutrophil count increased † 1  0/38 (0.00%)  1/19 (5.26%)  2/209 (0.96%)  2/245 (0.82%)  0/95 (0.00%)  0/6 (0.00%) 
Platelet count decreased † 1  0/38 (0.00%)  0/19 (0.00%)  20/209 (9.57%)  17/245 (6.94%)  3/95 (3.16%)  0/6 (0.00%) 
QRS axis abnormal † 1  0/38 (0.00%)  1/19 (5.26%)  0/209 (0.00%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Transaminases increased † 1  0/38 (0.00%)  2/19 (10.53%)  5/209 (2.39%)  4/245 (1.63%)  1/95 (1.05%)  1/6 (16.67%) 
Weight decreased † 1  4/38 (10.53%)  4/19 (21.05%)  59/209 (28.23%)  63/245 (25.71%)  39/95 (41.05%)  2/6 (33.33%) 
White blood cell count decreased † 1  1/38 (2.63%)  0/19 (0.00%)  19/209 (9.09%)  20/245 (8.16%)  2/95 (2.11%)  0/6 (0.00%) 
Metabolism and nutrition disorders             
Decreased appetite † 1  9/38 (23.68%)  10/19 (52.63%)  80/209 (38.28%)  92/245 (37.55%)  43/95 (45.26%)  4/6 (66.67%) 
Dehydration † 1  3/38 (7.89%)  4/19 (21.05%)  21/209 (10.05%)  30/245 (12.24%)  12/95 (12.63%)  0/6 (0.00%) 
Glucose tolerance impaired † 1  0/38 (0.00%)  1/19 (5.26%)  6/209 (2.87%)  9/245 (3.67%)  11/95 (11.58%)  0/6 (0.00%) 
Gout † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  0/245 (0.00%)  0/95 (0.00%)  1/6 (16.67%) 
Hyperglycaemia † 1  4/38 (10.53%)  10/19 (52.63%)  113/209 (54.07%)  147/245 (60.00%)  56/95 (58.95%)  3/6 (50.00%) 
Hyperkalaemia † 1  1/38 (2.63%)  1/19 (5.26%)  7/209 (3.35%)  6/245 (2.45%)  2/95 (2.11%)  0/6 (0.00%) 
Hypoalbuminaemia † 1  2/38 (5.26%)  2/19 (10.53%)  18/209 (8.61%)  22/245 (8.98%)  3/95 (3.16%)  0/6 (0.00%) 
Hypocalcaemia † 1  0/38 (0.00%)  1/19 (5.26%)  6/209 (2.87%)  11/245 (4.49%)  2/95 (2.11%)  0/6 (0.00%) 
Hypoglycaemia † 1  2/38 (5.26%)  0/19 (0.00%)  2/209 (0.96%)  8/245 (3.27%)  6/95 (6.32%)  0/6 (0.00%) 
Hypokalaemia † 1  0/38 (0.00%)  1/19 (5.26%)  27/209 (12.92%)  44/245 (17.96%)  14/95 (14.74%)  1/6 (16.67%) 
Hypomagnesaemia † 1  0/38 (0.00%)  0/19 (0.00%)  25/209 (11.96%)  30/245 (12.24%)  10/95 (10.53%)  2/6 (33.33%) 
Hyponatraemia † 1  0/38 (0.00%)  2/19 (10.53%)  25/209 (11.96%)  24/245 (9.80%)  8/95 (8.42%)  1/6 (16.67%) 
Musculoskeletal and connective tissue disorders             
Arthralgia † 1  5/38 (13.16%)  3/19 (15.79%)  23/209 (11.00%)  31/245 (12.65%)  13/95 (13.68%)  0/6 (0.00%) 
Back pain † 1  6/38 (15.79%)  3/19 (15.79%)  26/209 (12.44%)  43/245 (17.55%)  15/95 (15.79%)  0/6 (0.00%) 
Bone pain † 1  0/38 (0.00%)  2/19 (10.53%)  4/209 (1.91%)  4/245 (1.63%)  0/95 (0.00%)  0/6 (0.00%) 
Flank pain † 1  0/38 (0.00%)  1/19 (5.26%)  5/209 (2.39%)  4/245 (1.63%)  3/95 (3.16%)  0/6 (0.00%) 
Joint swelling † 1  0/38 (0.00%)  0/19 (0.00%)  2/209 (0.96%)  1/245 (0.41%)  3/95 (3.16%)  1/6 (16.67%) 
Muscle spasms † 1  4/38 (10.53%)  6/19 (31.58%)  57/209 (27.27%)  71/245 (28.98%)  27/95 (28.42%)  2/6 (33.33%) 
Muscular weakness † 1  0/38 (0.00%)  1/19 (5.26%)  9/209 (4.31%)  12/245 (4.90%)  5/95 (5.26%)  0/6 (0.00%) 
Musculoskeletal chest pain † 1  3/38 (7.89%)  2/19 (10.53%)  12/209 (5.74%)  21/245 (8.57%)  13/95 (13.68%)  1/6 (16.67%) 
Musculoskeletal discomfort † 1  2/38 (5.26%)  0/19 (0.00%)  2/209 (0.96%)  1/245 (0.41%)  0/95 (0.00%)  0/6 (0.00%) 
Musculoskeletal pain † 1  8/38 (21.05%)  1/19 (5.26%)  20/209 (9.57%)  22/245 (8.98%)  10/95 (10.53%)  0/6 (0.00%) 
Myalgia † 1  5/38 (13.16%)  4/19 (21.05%)  23/209 (11.00%)  16/245 (6.53%)  10/95 (10.53%)  1/6 (16.67%) 
Pain in extremity † 1  3/38 (7.89%)  0/19 (0.00%)  14/209 (6.70%)  23/245 (9.39%)  5/95 (5.26%)  0/6 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Malignant neoplasm progression † 1  11/38 (28.95%)  5/19 (26.32%)  28/209 (13.40%)  38/245 (15.51%)  26/95 (27.37%)  1/6 (16.67%) 
Nervous system disorders             
Ageusia † 1  0/38 (0.00%)  1/19 (5.26%)  0/209 (0.00%)  2/245 (0.82%)  0/95 (0.00%)  0/6 (0.00%) 
Amnesia † 1  1/38 (2.63%)  1/19 (5.26%)  4/209 (1.91%)  2/245 (0.82%)  1/95 (1.05%)  0/6 (0.00%) 
Ataxia † 1  0/38 (0.00%)  1/19 (5.26%)  1/209 (0.48%)  3/245 (1.22%)  2/95 (2.11%)  0/6 (0.00%) 
Balance disorder † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  3/245 (1.22%)  0/95 (0.00%)  1/6 (16.67%) 
Disturbance in attention † 1  0/38 (0.00%)  1/19 (5.26%)  1/209 (0.48%)  1/245 (0.41%)  1/95 (1.05%)  0/6 (0.00%) 
Dizziness † 1  4/38 (10.53%)  4/19 (21.05%)  25/209 (11.96%)  41/245 (16.73%)  14/95 (14.74%)  1/6 (16.67%) 
Dysarthria † 1  0/38 (0.00%)  2/19 (10.53%)  0/209 (0.00%)  0/245 (0.00%)  2/95 (2.11%)  0/6 (0.00%) 
Dysgeusia † 1  1/38 (2.63%)  2/19 (10.53%)  17/209 (8.13%)  16/245 (6.53%)  5/95 (5.26%)  0/6 (0.00%) 
Headache † 1  6/38 (15.79%)  5/19 (26.32%)  57/209 (27.27%)  57/245 (23.27%)  20/95 (21.05%)  1/6 (16.67%) 
Hemiparesis † 1  0/38 (0.00%)  1/19 (5.26%)  3/209 (1.44%)  1/245 (0.41%)  1/95 (1.05%)  0/6 (0.00%) 
Hypoaesthesia † 1  1/38 (2.63%)  3/19 (15.79%)  5/209 (2.39%)  6/245 (2.45%)  2/95 (2.11%)  0/6 (0.00%) 
Neuropathy peripheral † 1  1/38 (2.63%)  1/19 (5.26%)  5/209 (2.39%)  9/245 (3.67%)  4/95 (4.21%)  0/6 (0.00%) 
Paraesthesia † 1  2/38 (5.26%)  0/19 (0.00%)  10/209 (4.78%)  17/245 (6.94%)  4/95 (4.21%)  0/6 (0.00%) 
Restless legs syndrome † 1  0/38 (0.00%)  1/19 (5.26%)  0/209 (0.00%)  0/245 (0.00%)  1/95 (1.05%)  0/6 (0.00%) 
Seizure † 1  0/38 (0.00%)  0/19 (0.00%)  1/209 (0.48%)  6/245 (2.45%)  5/95 (5.26%)  0/6 (0.00%) 
Tension headache † 1  0/38 (0.00%)  1/19 (5.26%)  0/209 (0.00%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Tremor † 1  1/38 (2.63%)  3/19 (15.79%)  7/209 (3.35%)  7/245 (2.86%)  4/95 (4.21%)  1/6 (16.67%) 
Vocal cord paralysis † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  1/245 (0.41%)  0/95 (0.00%)  1/6 (16.67%) 
Psychiatric disorders             
Anxiety † 1  0/38 (0.00%)  2/19 (10.53%)  19/209 (9.09%)  20/245 (8.16%)  8/95 (8.42%)  1/6 (16.67%) 
Confusional state † 1  0/38 (0.00%)  0/19 (0.00%)  8/209 (3.83%)  13/245 (5.31%)  3/95 (3.16%)  0/6 (0.00%) 
Depression † 1  3/38 (7.89%)  3/19 (15.79%)  8/209 (3.83%)  12/245 (4.90%)  4/95 (4.21%)  1/6 (16.67%) 
Insomnia † 1  4/38 (10.53%)  2/19 (10.53%)  19/209 (9.09%)  31/245 (12.65%)  8/95 (8.42%)  0/6 (0.00%) 
Renal and urinary disorders             
Micturition urgency † 1  0/38 (0.00%)  1/19 (5.26%)  0/209 (0.00%)  2/245 (0.82%)  0/95 (0.00%)  0/6 (0.00%) 
Pollakiuria † 1  1/38 (2.63%)  1/19 (5.26%)  8/209 (3.83%)  12/245 (4.90%)  1/95 (1.05%)  0/6 (0.00%) 
Renal impairment † 1  0/38 (0.00%)  1/19 (5.26%)  0/209 (0.00%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Urge incontinence † 1  0/38 (0.00%)  1/19 (5.26%)  0/209 (0.00%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Urinary tract disorder † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  0/245 (0.00%)  0/95 (0.00%)  1/6 (16.67%) 
Respiratory, thoracic and mediastinal disorders             
Apnoea † 1  0/38 (0.00%)  1/19 (5.26%)  0/209 (0.00%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Cough † 1  9/38 (23.68%)  3/19 (15.79%)  62/209 (29.67%)  59/245 (24.08%)  15/95 (15.79%)  1/6 (16.67%) 
Dysphonia † 1  2/38 (5.26%)  1/19 (5.26%)  4/209 (1.91%)  6/245 (2.45%)  2/95 (2.11%)  0/6 (0.00%) 
Dypnoea † 1  10/38 (26.32%)  2/19 (10.53%)  51/209 (24.40%)  65/245 (26.53%)  20/95 (21.05%)  2/6 (33.33%) 
Dyspnoea exertional † 1  3/38 (7.89%)  0/19 (0.00%)  12/209 (5.74%)  9/245 (3.67%)  7/95 (7.37%)  0/6 (0.00%) 
Epistaxis † 1  2/38 (5.26%)  2/19 (10.53%)  7/209 (3.35%)  12/245 (4.90%)  2/95 (2.11%)  0/6 (0.00%) 
Haemoptysis † 1  1/38 (2.63%)  1/19 (5.26%)  3/209 (1.44%)  12/245 (4.90%)  1/95 (1.05%)  1/6 (16.67%) 
Hypoxia † 1  0/38 (0.00%)  2/19 (10.53%)  6/209 (2.87%)  7/245 (2.86%)  2/95 (2.11%)  0/6 (0.00%) 
Nasal congestion † 1  1/38 (2.63%)  1/19 (5.26%)  6/209 (2.87%)  7/245 (2.86%)  2/95 (2.11%)  0/6 (0.00%) 
Oropharyngeal pain † 1  2/38 (5.26%)  0/19 (0.00%)  8/209 (3.83%)  7/245 (2.86%)  1/95 (1.05%)  0/6 (0.00%) 
Paranasal sinus hypersecretion † 1  2/38 (5.26%)  0/19 (0.00%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Pleural effusion † 1  2/38 (5.26%)  2/19 (10.53%)  6/209 (2.87%)  13/245 (5.31%)  5/95 (5.26%)  1/6 (16.67%) 
Pleuritic pain † 1  3/38 (7.89%)  2/19 (10.53%)  1/209 (0.48%)  4/245 (1.63%)  1/95 (1.05%)  0/6 (0.00%) 
Pneumonitis † 1  1/38 (2.63%)  1/19 (5.26%)  1/209 (0.48%)  7/245 (2.86%)  3/95 (3.16%)  0/6 (0.00%) 
Pulmonary embolism † 1  0/38 (0.00%)  1/19 (5.26%)  5/209 (2.39%)  6/245 (2.45%)  2/95 (2.11%)  1/6 (16.67%) 
Pulmonary hypertension † 1  0/38 (0.00%)  1/19 (5.26%)  0/209 (0.00%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Respiratory distress † 1  0/38 (0.00%)  0/19 (0.00%)  2/209 (0.96%)  0/245 (0.00%)  1/95 (1.05%)  1/6 (16.67%) 
Respiratory failure † 1  0/38 (0.00%)  1/19 (5.26%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Throat tightness † 1  0/38 (0.00%)  1/19 (5.26%)  1/209 (0.48%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Wheezing † 1  1/38 (2.63%)  1/19 (5.26%)  4/209 (1.91%)  3/245 (1.22%)  2/95 (2.11%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders             
Alopecia † 1  2/38 (5.26%)  0/19 (0.00%)  13/209 (6.22%)  9/245 (3.67%)  11/95 (11.58%)  0/6 (0.00%) 
Dry skin † 1  1/38 (2.63%)  3/19 (15.79%)  14/209 (6.70%)  18/245 (7.35%)  5/95 (5.26%)  1/6 (16.67%) 
Photosensitivity reaction † 1  0/38 (0.00%)  1/19 (5.26%)  0/209 (0.00%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Pruritis † 1  1/38 (2.63%)  1/19 (5.26%)  5/209 (2.39%)  12/245 (4.90%)  4/95 (4.21%)  0/6 (0.00%) 
Rash † 1  3/38 (7.89%)  2/19 (10.53%)  17/209 (8.13%)  13/245 (5.31%)  12/95 (12.63%)  0/6 (0.00%) 
Rash morbilliform † 1  0/38 (0.00%)  1/19 (5.26%)  0/209 (0.00%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Skin erosion † 1  0/38 (0.00%)  0/19 (0.00%)  0/209 (0.00%)  0/245 (0.00%)  0/95 (0.00%)  1/6 (16.67%) 
Vascular disorders             
Flushing † 1  2/38 (5.26%)  0/19 (0.00%)  0/209 (0.00%)  0/245 (0.00%)  0/95 (0.00%)  0/6 (0.00%) 
Hypertension † 1  5/38 (13.16%)  0/19 (0.00%)  16/209 (7.66%)  11/245 (4.49%)  7/95 (7.37%)  0/6 (0.00%) 
Hypotension † 1  0/38 (0.00%)  1/19 (5.26%)  4/209 (1.91%)  9/245 (3.67%)  2/95 (2.11%)  0/6 (0.00%) 
1
Term from vocabulary, MedDRA (18.0)
†
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.
All parties agree to submit all manuscripts or abstracts to all other parties 30 days prior to submission. This will enable all parties to protect proprietary information and to provide comments based on information that may not yet be available to other parties. The sponsor may request a delay in publication if there are important intellectual property concerns relating to publication, but does not have the right to suppress publication of the study results indefinitely.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Information Department
Organization: Clovis Oncology
Phone: +1 415 409 7220
EMail: medinfo@clovisoncology.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Clovis Oncology, Inc.
ClinicalTrials.gov Identifier: NCT01526928    
Other Study ID Numbers: CO-1686-008
First Submitted: January 31, 2012
First Posted: February 6, 2012
Results First Submitted: June 11, 2019
Results First Posted: January 6, 2020
Last Update Posted: August 4, 2020