Trial Outcomes & Findings for A Study of Paclitaxel/Carboplatin With or Without CDP791 in Patients With Lung Cancer (NCT NCT00152477)

Last Updated: 2022-04-12

Results Overview

Participants are evaluated for response using Response Evaluation Criteria in Solid Tumors (RECIST) (Therasse P et al; 2000). The tumor response rate is calculated as the total number of subjects whose best overall response is a complete response (CR)= disappearance of all target lesions; or a partial response (PR) = \>=30 % decrease in the sum of the longest diameter of target lesions, divided by the number of randomized subjects (RS): (CR + PR) / RS.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

165 participants

Primary outcome timeframe

24 weeks

Results posted on

2022-04-12

Participant Flow

The study started to enroll patients in August 2005 and concluded in June 2009. Across Part I (dose escalation) and Part II (Open Label randomized) of the study, 165 subjects were analyzed. Part II was opened for 156 response-evaluable subjects.

Participant Flow refers to the Randomized Set.

Participant milestones

Participant milestones
Measure	Carboplatin/Paclitaxel Carboplatin and paclitaxel alone	Carboplatin/Paclitaxel/CDP791 10mg Carboplatin and paclitaxel plus CDP791 10mg/kg	Carboplatin/Paclitaxel/CDP791 20mg Carboplatin and paclitaxel plus CDP791 20mg/kg
Chemotherapy Period STARTED	50	56	59
Chemotherapy Period Part II	50	53	53
Chemotherapy Period COMPLETED	22	34	39
Chemotherapy Period NOT COMPLETED	28	22	20
Monotherapy Period STARTED	15	29	34
Monotherapy Period Part II	13	26	29
Monotherapy Period COMPLETED	0	0	0
Monotherapy Period NOT COMPLETED	15	29	34

Reasons for withdrawal

Reasons for withdrawal
Measure	Carboplatin/Paclitaxel Carboplatin and paclitaxel alone	Carboplatin/Paclitaxel/CDP791 10mg Carboplatin and paclitaxel plus CDP791 10mg/kg	Carboplatin/Paclitaxel/CDP791 20mg Carboplatin and paclitaxel plus CDP791 20mg/kg
Chemotherapy Period Adverse Event	9	4	5
Chemotherapy Period Death	1	3	3
Chemotherapy Period Lack of Efficacy	4	5	6
Chemotherapy Period Lost to Follow-up	1	0	1
Chemotherapy Period Protocol Violation	1	1	0
Chemotherapy Period Withdrawal by Subject	5	1	0
Chemotherapy Period Progression of Disease	6	8	4
Chemotherapy Period Investigator decision	0	0	1
Chemotherapy Period Patient condition worsened	1	0	0
Monotherapy Period Adverse Event	1	0	5
Monotherapy Period Death	2	0	1
Monotherapy Period Lack of Efficacy	7	16	10
Monotherapy Period Protocol Violation	0	1	0
Monotherapy Period Withdrawal by Subject	0	0	4
Monotherapy Period Progression of Disease	5	11	12
Monotherapy Period Patient decision	0	1	1
Monotherapy Period Study personel decision	0	0	1

Baseline Characteristics

A Study of Paclitaxel/Carboplatin With or Without CDP791 in Patients With Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Carboplatin/Paclitaxel n=50 Participants Carboplatin and paclitaxel alone	Carboplatin/Paclitaxel/CDP791 10mg n=53 Participants Carboplatin and paclitaxel plus CDP791 10mg/kg	Carboplatin/Paclitaxel/CDP791 20mg n=53 Participants Carboplatin and paclitaxel plus CDP791 20mg/kg	Total Title n=156 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	35 Participants n=7 Participants	40 Participants n=5 Participants	105 Participants n=4 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants	18 Participants n=7 Participants	13 Participants n=5 Participants	51 Participants n=4 Participants
Age, Continuous	61.58 years STANDARD_DEVIATION 10.69 • n=5 Participants	60.70 years STANDARD_DEVIATION 10.01 • n=7 Participants	58.25 years STANDARD_DEVIATION 9.38 • n=5 Participants	60.15 years STANDARD_DEVIATION 10.06 • n=4 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	21 Participants n=7 Participants	29 Participants n=5 Participants	70 Participants n=4 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	32 Participants n=7 Participants	24 Participants n=5 Participants	86 Participants n=4 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: All Randomized Part II Subjects

Outcome measures

Outcome measures
Measure	Carboplatin/Paclitaxel (Randomized Part II SjS) n=50 Participants Carboplatin and paclitaxel alone (Randomized Part II Subjects Set \[SjS\])	Carboplatin/Paclitaxel/CDP791 (Randomized Part II SjS) n=106 Participants Pooled CDP791 10 mg/kg or 20 mg/kg + CT treatment arms	Carboplatin/Paclitaxel/CDP791 10mg (Randomized Part II SS) n=53 Participants Carboplatin and paclitaxel plus CDP791 10mg/kg (Randomized Part II Subjects Set \[SjS\])	Carboplatin/Paclitaxel/CDP791 20mg (Randomized Part II SjS) n=53 Participants Carboplatin and paclitaxel plus CDP791 20mg/kg (Randomized Part II Subjects Set \[SjS\])
Tumor Response Rate (RR) Complete responder	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Tumor Response Rate (RR) Partial responder	20 percentage of participants	26.4 percentage of participants	22.6 percentage of participants	30.2 percentage of participants

SECONDARY outcome

Timeframe: Up to 57 weeks

Population: All Randomized Part II Subjects

Progression free survival (PFS) is defined as time from date of randomization until the date progressive disease (PD) is first recorded or until death, whichever is first.

Outcome measures

Outcome measures
Measure	Carboplatin/Paclitaxel (Randomized Part II SjS) n=50 Participants Carboplatin and paclitaxel alone (Randomized Part II Subjects Set \[SjS\])	Carboplatin/Paclitaxel/CDP791 (Randomized Part II SjS) n=106 Participants Pooled CDP791 10 mg/kg or 20 mg/kg + CT treatment arms	Carboplatin/Paclitaxel/CDP791 10mg (Randomized Part II SS) n=53 Participants Carboplatin and paclitaxel plus CDP791 10mg/kg (Randomized Part II Subjects Set \[SjS\])	Carboplatin/Paclitaxel/CDP791 20mg (Randomized Part II SjS) n=53 Participants Carboplatin and paclitaxel plus CDP791 20mg/kg (Randomized Part II Subjects Set \[SjS\])
Progression Free Survival (PFS)	24.14 weeks Interval 20.29 to 29.29	26.86 weeks Interval 24.43 to 30.14	26.86 weeks Interval 21.14 to 30.71	25.43 weeks Interval 24.29 to 30.43

SECONDARY outcome

Timeframe: Up to 57 weeks

Population: All Randomized Part II Subjects

Time to treatment failure (TTF) is defined as the time from date of randomization until the date of progression, death or, for subjects who discontinued treatment for toxicity reason, their last dosing date, whichever occurs first.

Outcome measures

Outcome measures
Measure	Carboplatin/Paclitaxel (Randomized Part II SjS) n=50 Participants Carboplatin and paclitaxel alone (Randomized Part II Subjects Set \[SjS\])	Carboplatin/Paclitaxel/CDP791 (Randomized Part II SjS) n=106 Participants Pooled CDP791 10 mg/kg or 20 mg/kg + CT treatment arms	Carboplatin/Paclitaxel/CDP791 10mg (Randomized Part II SS) n=53 Participants Carboplatin and paclitaxel plus CDP791 10mg/kg (Randomized Part II Subjects Set \[SjS\])	Carboplatin/Paclitaxel/CDP791 20mg (Randomized Part II SjS) n=53 Participants Carboplatin and paclitaxel plus CDP791 20mg/kg (Randomized Part II Subjects Set \[SjS\])
Time to Treatment Failure	13.21 weeks Interval 6.86 to 20.29	21.71 weeks Interval 18.14 to 24.71	18.43 weeks Interval 12.14 to 24.71	24.29 weeks Interval 18.14 to 27.0

SECONDARY outcome

Timeframe: Up to 57 weeks

Population: All Randomized Part II Subjects

Overall survival is defined as the time from date of randomization until the date of death.

Outcome measures

Outcome measures
Measure	Carboplatin/Paclitaxel (Randomized Part II SjS) n=50 Participants Carboplatin and paclitaxel alone (Randomized Part II Subjects Set \[SjS\])	Carboplatin/Paclitaxel/CDP791 (Randomized Part II SjS) n=106 Participants Pooled CDP791 10 mg/kg or 20 mg/kg + CT treatment arms	Carboplatin/Paclitaxel/CDP791 10mg (Randomized Part II SS) n=53 Participants Carboplatin and paclitaxel plus CDP791 10mg/kg (Randomized Part II Subjects Set \[SjS\])	Carboplatin/Paclitaxel/CDP791 20mg (Randomized Part II SjS) n=53 Participants Carboplatin and paclitaxel plus CDP791 20mg/kg (Randomized Part II Subjects Set \[SjS\])
Overall Survival	36.14 weeks Interval 27.14 to 64.14	47.14 weeks Interval 40.43 to 56.0	46.57 weeks Interval 38.57 to 59.86	47.57 weeks Interval 31.29 to 75.0

SECONDARY outcome

Timeframe: Up to 57 weeks

Population: The duration of overall response was computed for subjects only, whose best response was either PR or CR.

The duration of overall response is measured from the time measurement criteria are first met for complete response (CR) or partial response (PR), whichever is recorded first, until the first date of documented progressive disease or death.

Outcome measures

Outcome measures
Measure	Carboplatin/Paclitaxel (Randomized Part II SjS) n=10 Participants Carboplatin and paclitaxel alone (Randomized Part II Subjects Set \[SjS\])	Carboplatin/Paclitaxel/CDP791 (Randomized Part II SjS) n=28 Participants Pooled CDP791 10 mg/kg or 20 mg/kg + CT treatment arms	Carboplatin/Paclitaxel/CDP791 10mg (Randomized Part II SS) n=12 Participants Carboplatin and paclitaxel plus CDP791 10mg/kg (Randomized Part II Subjects Set \[SjS\])	Carboplatin/Paclitaxel/CDP791 20mg (Randomized Part II SjS) n=16 Participants Carboplatin and paclitaxel plus CDP791 20mg/kg (Randomized Part II Subjects Set \[SjS\])
Duration of Overall Response	21.14 weeks Interval 19.14 to Upper limit is not estimable due to insufficient number of responding patients who later go on to disease progression or death.	21.14 weeks Interval 16.86 to 22.43	21.14 weeks Interval 19.29 to Upper limit is not estimable due to insufficient number of responding patients who later go on to disease progression or death.	18.00 weeks Interval 16.71 to 22.43

SECONDARY outcome

Timeframe: Week 24

Population: The time to response was computed for subjects only, whose best response was either PR or CR.

Time to response is defined as the time from the first dose of study therapy until measurement criteria are first met for complete response or partial response (whichever is recorded first).

Outcome measures

Outcome measures
Measure	Carboplatin/Paclitaxel (Randomized Part II SjS) n=10 Participants Carboplatin and paclitaxel alone (Randomized Part II Subjects Set \[SjS\])	Carboplatin/Paclitaxel/CDP791 (Randomized Part II SjS) n=28 Participants Pooled CDP791 10 mg/kg or 20 mg/kg + CT treatment arms	Carboplatin/Paclitaxel/CDP791 10mg (Randomized Part II SS) n=12 Participants Carboplatin and paclitaxel plus CDP791 10mg/kg (Randomized Part II Subjects Set \[SjS\])	Carboplatin/Paclitaxel/CDP791 20mg (Randomized Part II SjS) n=16 Participants Carboplatin and paclitaxel plus CDP791 20mg/kg (Randomized Part II Subjects Set \[SjS\])
Time to Response	8.57 weeks Interval 8.14 to 17.43	9.14 weeks Interval 8.36 to 16.64	11.86 weeks Interval 8.86 to 16.64	9.00 weeks Interval 8.21 to 15.29

Adverse Events

Carboplatin/Paclitaxel (SS)

Serious events: 18 serious events

Other events: 44 other events

Deaths: 30 deaths

Carboplatin/Paclitaxel/CDP791 (SS)

Serious events: 36 serious events

Other events: 110 other events

Deaths: 72 deaths

Carboplatin/Paclitaxel/CDP791 10mg (SS)

Serious events: 18 serious events

Other events: 54 other events

Deaths: 39 deaths

Carboplatin/Paclitaxel/CDP791 20mg (SS)

Serious events: 18 serious events

Other events: 56 other events

Deaths: 33 deaths

Serious adverse events

Other adverse events

Additional Information

UCB

Cares

Phone: +1844 599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Serious adverse events
Measure	Carboplatin/Paclitaxel (SS) n=50 participants at risk Carboplatin and paclitaxel alone.	Carboplatin/Paclitaxel/CDP791 (SS) n=115 participants at risk Pooled CDP791 10 mg/kg or 20 mg/kg + CT treatment arms	Carboplatin/Paclitaxel/CDP791 10mg (SS) n=56 participants at risk Carboplatin and paclitaxel plus CDP791 10mg/kg	Carboplatin/Paclitaxel/CDP791 20mg (SS) n=56 participants at risk；n=59 participants at risk Carboplatin and paclitaxel plus CDP791 20mg/kg
Blood and lymphatic system disorders Agranulocytosis	0.00% 0/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.87% 1/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.8% 1/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Blood and lymphatic system disorders Anaemia	8.0% 4/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	5.2% 6/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	3.6% 2/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	6.8% 4/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Blood and lymphatic system disorders Granulocytopenia	0.00% 0/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.87% 1/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.8% 1/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Blood and lymphatic system disorders Leukopenia	0.00% 0/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.7% 2/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.8% 1/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.7% 1/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Blood and lymphatic system disorders Neutropenia	0.00% 0/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.87% 1/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.7% 1/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	4.3% 5/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	3.6% 2/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	5.1% 3/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Cardiac disorders Cardiac failure	2.0% 1/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.87% 1/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.7% 1/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Cardiac disorders Cardiopulmonary failure	2.0% 1/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.87% 1/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.8% 1/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Cardiac disorders Myocardial ischaemia	2.0% 1/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Cardiac disorders Pericardial effusion	2.0% 1/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.87% 1/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.7% 1/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Cardiac disorders Supraventricular tachycardia	2.0% 1/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.87% 1/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.7% 1/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Gastrointestinal disorders Dysphagia	0.00% 0/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.87% 1/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.7% 1/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Gastrointestinal disorders Pancreatic pseudocyst	0.00% 0/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.87% 1/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.7% 1/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Gastrointestinal disorders Pancreatitis	0.00% 0/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.87% 1/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.7% 1/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
General disorders Asthenia	2.0% 1/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
General disorders Chest pain	0.00% 0/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.87% 1/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.8% 1/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
General disorders Condition aggravated	2.0% 1/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
General disorders Death	0.00% 0/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.87% 1/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.8% 1/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
General disorders Fatigue	2.0% 1/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.7% 2/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	3.4% 2/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
General disorders General physical health deterioration	0.00% 0/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.7% 2/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.8% 1/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.7% 1/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
General disorders Oedema peripheral	4.0% 2/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
General disorders Pyrexia	0.00% 0/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.87% 1/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.8% 1/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
General disorders Sudden death	0.00% 0/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.87% 1/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.8% 1/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Hepatobiliary disorders Liver disorder	0.00% 0/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.87% 1/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.8% 1/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Immune system disorders Drug hypersensitivity	2.0% 1/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Immune system disorders Hypersensitivity	0.00% 0/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.87% 1/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.8% 1/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Infections and infestations Bronchopneumonia	0.00% 0/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.87% 1/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.7% 1/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Infections and infestations Injection site abscess	0.00% 0/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.87% 1/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.8% 1/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Infections and infestations Pneumonia	0.00% 0/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.7% 2/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.8% 1/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.7% 1/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Infections and infestations Pneumonia primary atypical	0.00% 0/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.87% 1/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.7% 1/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.87% 1/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.7% 1/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Investigations Scan abnormal	0.00% 0/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.87% 1/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.7% 1/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Investigations Transaminases increased	0.00% 0/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.87% 1/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.8% 1/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Investigations Weight decreased	2.0% 1/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	2.6% 3/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	3.6% 2/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.7% 1/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Metabolism and nutrition disorders Dehydration	0.00% 0/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.7% 2/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.8% 1/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.7% 1/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.87% 1/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.7% 1/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	2.0% 1/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.87% 1/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.8% 1/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	12.0% 6/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.7% 2/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	3.4% 2/59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.

Other adverse events
Measure	Carboplatin/Paclitaxel (SS) n=50 participants at risk Carboplatin and paclitaxel alone.	Carboplatin/Paclitaxel/CDP791 (SS) n=115 participants at risk Pooled CDP791 10 mg/kg or 20 mg/kg + CT treatment arms	Carboplatin/Paclitaxel/CDP791 10mg (SS) n=56 participants at risk Carboplatin and paclitaxel plus CDP791 10mg/kg	Carboplatin/Paclitaxel/CDP791 20mg (SS) n=56 participants at risk；n=59 participants at risk Carboplatin and paclitaxel plus CDP791 20mg/kg
Blood and lymphatic system disorders Anaemia	34.0% 17/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	30.4% 35/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	30.4% 17/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	32.1% 18/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Blood and lymphatic system disorders Granulocytopenia	0.00% 0/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	4.3% 5/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	7.1% 4/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.8% 1/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Blood and lymphatic system disorders Leukopenia	8.0% 4/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	20.0% 23/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	25.0% 14/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	16.1% 9/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Blood and lymphatic system disorders Neutropenia	30.0% 15/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	36.5% 42/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	33.9% 19/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	41.1% 23/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	16.0% 8/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	16.5% 19/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	14.3% 8/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	19.6% 11/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	2.0% 1/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	2.6% 3/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	5.4% 3/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Gastrointestinal disorders Constipation	4.0% 2/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	3.5% 4/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	7.1% 4/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	6.0% 3/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	7.8% 9/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	3.6% 2/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	12.5% 7/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Gastrointestinal disorders Dyspepsia	0.00% 0/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	2.6% 3/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	5.4% 3/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Gastrointestinal disorders Nausea	14.0% 7/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	13.9% 16/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	10.7% 6/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	17.9% 10/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Gastrointestinal disorders Stomatitis	2.0% 1/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	3.5% 4/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	5.4% 3/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.8% 1/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Gastrointestinal disorders Vomiting	16.0% 8/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	7.8% 9/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	8.9% 5/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	7.1% 4/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
General disorders Asthenia	6.0% 3/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	7.8% 9/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	7.1% 4/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	8.9% 5/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
General disorders Chest pain	8.0% 4/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	7.8% 9/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	8.9% 5/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	7.1% 4/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
General disorders Fatigue	20.0% 10/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	13.9% 16/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	16.1% 9/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	12.5% 7/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
General disorders Oedema peripheral	6.0% 3/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	8.7% 10/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	8.9% 5/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	8.9% 5/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
General disorders Pyrexia	4.0% 2/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	7.0% 8/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	7.1% 4/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	7.1% 4/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Infections and infestations Urinary tract infection	2.0% 1/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	5.2% 6/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.8% 1/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	8.9% 5/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Investigations Blood alkaline phosphatase increased	4.0% 2/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	4.3% 5/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	3.6% 2/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	5.4% 3/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Investigations Blood creatinine increased	2.0% 1/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	4.3% 5/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	3.6% 2/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	5.4% 3/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Investigations Blood glucose increased	4.0% 2/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	10.4% 12/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	14.3% 8/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	7.1% 4/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Investigations Gamma-glutamyltransferase increased	6.0% 3/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	7.0% 8/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	7.1% 4/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	7.1% 4/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Investigations Weight decreased	6.0% 3/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	5.2% 6/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	5.4% 3/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	5.4% 3/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Metabolism and nutrition disorders Anorexia	12.0% 6/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	15.7% 18/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	14.3% 8/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	17.9% 10/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	3.5% 4/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.8% 1/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	5.4% 3/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	4.0% 2/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	12.2% 14/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	7.1% 4/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	17.9% 10/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	4.0% 2/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	2.6% 3/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	5.4% 3/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Musculoskeletal and connective tissue disorders Bone pain	2.0% 1/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	13.0% 15/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	10.7% 6/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	16.1% 9/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	10.0% 5/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	4.3% 5/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.8% 1/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	7.1% 4/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	4.0% 2/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	2.6% 3/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	5.4% 3/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	0.00% 0/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Nervous system disorders Neuropathy	6.0% 3/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	3.5% 4/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	3.6% 2/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	3.6% 2/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Nervous system disorders Neuropathy peripheral	0.00% 0/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	3.5% 4/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.8% 1/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	5.4% 3/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Nervous system disorders Paraesthesia	10.0% 5/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	4.3% 5/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.8% 1/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	7.1% 4/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Nervous system disorders Peripheral sensory neuropathy	14.0% 7/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	10.4% 12/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	12.5% 7/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	8.9% 5/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Nervous system disorders Polyneuropathy	4.0% 2/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	3.5% 4/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.8% 1/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	5.4% 3/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Psychiatric disorders Insomnia	6.0% 3/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	3.5% 4/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.8% 1/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	5.4% 3/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Renal and urinary disorders Haematuria	2.0% 1/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	7.8% 9/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	5.4% 3/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	10.7% 6/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Renal and urinary disorders Proteinuria	2.0% 1/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	11.3% 13/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	12.5% 7/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	10.7% 6/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	12.0% 6/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.7% 2/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.8% 1/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	1.8% 1/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.0% 3/50 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	8.7% 10/115 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	7.1% 4/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.	10.7% 6/56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (for up to 57 weeks). All Treated Subjects: all subjects who took at least one dose of study drug.