Trial Outcomes & Findings for Ph II Trial of Carboplatin and Pemetrexed With or Without AZD1775 for Untreated Lung Cancer (NCT NCT02087241)

NCT ID: NCT02087241

Last Updated: 2017-03-29

Results Overview

Progression free survival is defined as the time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the subject withdraws from randomised therapy or receives another anti-cancer therapy prior to progression.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

6 months

Results posted on

2017-03-29

Participant Flow

The study was conducted at 16 clinical sites in the United States. A total of 14 subjects were enrolled between March 19, 2014 and April 16, 2015.

22 subjects were consented; 3 subjects failed screening. The study was terminated prior to the start of screening for 5 participants. 14 participants were treated with AZD1775. The study was terminated early by the sponsor. Part 2 was not done. The 14 participants were enrolled in 4 Cohorts, designated Cohorts 1, 2, 3, and A.

Participant milestones

Participant milestones
Measure	Cohort 1 AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6	Cohort 2 AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.	Cohort 3 AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6	Cohort A AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5
Overall Study STARTED	3	3	1	7
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	3	3	1	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6	Cohort 2 AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.	Cohort 3 AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6	Cohort A AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5
Overall Study Death	2	1	1	1
Overall Study Withdrawal by Subject	1	0	0	1
Overall Study Progressive Disease	0	0	0	1
Overall Study Study Terminated by Sponsor	0	2	0	4

Baseline Characteristics

Ph II Trial of Carboplatin and Pemetrexed With or Without AZD1775 for Untreated Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 n=3 Participants AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6	Cohort 2 n=3 Participants AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.	Cohort 3 n=1 Participants AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6	Cohort A n=7 Participants AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5	Total n=14 Participants Total of all reporting groups
Age, Continuous	66.0 Years n=5 Participants	61.0 Years n=7 Participants	81.0 Years n=5 Participants	64.0 Years n=4 Participants	63.0 Years n=21 Participants
Age, Customized < 65	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	8 Participants n=21 Participants
Age, Customized >= 65	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	8 Participants n=21 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	6 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants	13 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants	13 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	3 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants	14 Participants n=21 Participants
Tobacco Use Smoker	3 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants	14 Participants n=21 Participants
Tobacco Use Non-Smoker	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
ECOG Performance Status ECOG Performance Status = 0	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants
ECOG Performance Status ECOG Performance Status = 1	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	8 Participants n=21 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Progression-Free Survival data were not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days)

The objective response rate is defined as the number of the subjects with a confirmed best overall response of CR or PR divided by the number of subjects in the Full Analysis Set (FAS) for whom measureable disease is present at baseline

Outcome measures

Outcome measures
Measure	Cohort 1 n=3 Participants AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.	Cohort 2 n=3 Participants AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.	Cohort 3 n=1 Participants AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6	Cohort A n=7 Participants AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5
Assess the Objective Response Rates in Each Arm	66.7 Percentage of Participants Interval 13.54 to 98.3	33.3 Percentage of Participants Interval 1.7 to 86.46	0 Percentage of Participants Interval 0.0 to 0.0	14.3 Percentage of Participants Interval 0.85 to 58.18

SECONDARY outcome

Timeframe: Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days)

the disease control rate is defined as the percentage of FAS subjects with a best overall response of CR, PR or SD).

Outcome measures

Outcome measures
Measure	Cohort 1 n=3 Participants AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.	Cohort 2 n=3 Participants AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.	Cohort 3 n=1 Participants AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6	Cohort A n=7 Participants AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5
Assess the Disease Control Rate in Each Treatment Arm	66.7 Percentage of Participants Interval 13.54 to 98.3	66.7 Percentage of Participants Interval 13.54 to 98.3	0 Percentage of Participants Interval 0.0 to 0.0	85.7 Percentage of Participants Interval 60.7 to 100.0

SECONDARY outcome

Timeframe: Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days)

Population: Duration of response data were not collected.

Duration of response is defined as the time from the date of first documented response until the date of documented progression or any cause death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days)

Population: Overall Survival (OS) data were not collected.

Overall survival is defined as the time from the date of randomization until death due to any cause.

Outcome measures

Outcome data not reported

Adverse Events

Cohort 1

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 2

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 3

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort A

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Charles H. Davis

SCRI Development Innovations

Phone: +615-524-4341

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Cohort 1 n=3 participants at risk AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6	Cohort 2 n=3 participants at risk AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.	Cohort 3 n=1 participants at risk AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6	Cohort A n=7 participants at risk AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21-Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	0.00% 0/3 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/3 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	14.3% 1/7 • Number of events 1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.
Blood and lymphatic system disorders NEUTROPENIA	0.00% 0/3 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	66.7% 2/3 • Number of events 2 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/7 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.
Blood and lymphatic system disorders PANCYTOPENIA	0.00% 0/3 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	33.3% 1/3 • Number of events 1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/7 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.00% 0/3 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	33.3% 1/3 • Number of events 1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/7 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.
Cardiac disorders ATRIAL FIBRILLATION	33.3% 1/3 • Number of events 1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/3 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/7 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.
Cardiac disorders MYOCARDIAL INFARCTION	0.00% 0/3 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/3 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	14.3% 1/7 • Number of events 1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/3 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	33.3% 1/3 • Number of events 1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/7 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.
Gastrointestinal disorders DIARRHOEA	0.00% 0/3 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	33.3% 1/3 • Number of events 1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/7 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	0.00% 0/3 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/3 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	100.0% 1/1 • Number of events 1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/7 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.
Gastrointestinal disorders STOMATITIS	0.00% 0/3 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	33.3% 1/3 • Number of events 1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/7 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.
Gastrointestinal disorders UPPER GASTROINTESTINAL HAEMORRHAGE	0.00% 0/3 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	33.3% 1/3 • Number of events 1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/7 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.
Gastrointestinal disorders VOMITING	0.00% 0/3 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	33.3% 1/3 • Number of events 1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/7 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.
General disorders MUCOSAL INFLAMMATION	0.00% 0/3 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	33.3% 1/3 • Number of events 1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/7 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.
Infections and infestations INFLUENZA	0.00% 0/3 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/3 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	14.3% 1/7 • Number of events 1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.
Investigations PLATELET COUNT DECREASED	0.00% 0/3 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	33.3% 1/3 • Number of events 1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/7 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.
Metabolism and nutrition disorders DEHYDRATION	0.00% 0/3 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	33.3% 1/3 • Number of events 1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	100.0% 1/1 • Number of events 1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/7 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.
Metabolism and nutrition disorders FAILURE TO THRIVE	0.00% 0/3 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/3 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	14.3% 1/7 • Number of events 1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.
Metabolism and nutrition disorders HYPOKALAEMIA	0.00% 0/3 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	33.3% 1/3 • Number of events 1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/7 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.00% 0/3 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/3 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	0.00% 0/1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.	14.3% 1/7 • Number of events 1 • 1 year, 3 months Adverse event data were collected from the time the first patient received the first dose of investigational drug on March 19, 2014 until the study was closed on June 1, 2015.