Trial Outcomes & Findings for Extension Trial of Deforolimus (Ridaforolimus, MK-8669) in Participants With Advanced Cancer (MK-8669-038) (NCT NCT00836927)

NCT ID: NCT00836927

Last Updated: 2019-02-18

Results Overview

An adverse event is defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a participant during a clinical study or the follow-up period, regardless of relationship to study drug. The number of participants who experienced an adverse event is presented.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 7 participants
• Primary outcome timeframe: Up to approximately 2991 days, including 30 days after the last dose (through data cut-off date of 03 Apr 2017)
• Results posted on: 2019-02-18

Participant Flow

Participants who continued to receive clinical benefit from ridaforolimus, or who were being followed for long-term safety and efficacy under the following prior protocols were eligible for enrollment into this extension study: MK-8669-013, NCT00060645; MK-8669-016, NCT00112372; and MK-8669-028, NCT00704054.

Participants may have continued ridaforolimus IV infusion at the same dose from the parent trial before being switched to ridaforolimus oral tablet.

Participant milestones

Measure	Ridaforolimus 10 mg Days 1-5 Ridaforolimus 10 mg administered orally once daily on Days 1-5 per week.	Ridaforolimus 10 mg Days 1-6 Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week.	Ridaforolimus 20 mg Days 1-5 Ridaforolimus 20 mg administered once daily on Days 1-5 per week.	Ridaforolimus 30 mg Days 1-5 Ridaforolimus 30 mg administered orally once daily on Days 1-5 per week.	Ridaforolimus 40 mg Days 1-5 Ridaforolimus 40 mg administered orally once daily on Days 1-5 per week.
Overall Study STARTED	3	1	1	1	1
Overall Study Completed Dosing Through 03 Apr 2017	0	1	1	0	0
Overall Study COMPLETED	0	1	1	0	0
Overall Study NOT COMPLETED	3	0	0	1	1

Reasons for withdrawal

Measure	Ridaforolimus 10 mg Days 1-5 Ridaforolimus 10 mg administered orally once daily on Days 1-5 per week.	Ridaforolimus 10 mg Days 1-6 Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week.	Ridaforolimus 20 mg Days 1-5 Ridaforolimus 20 mg administered once daily on Days 1-5 per week.	Ridaforolimus 30 mg Days 1-5 Ridaforolimus 30 mg administered orally once daily on Days 1-5 per week.	Ridaforolimus 40 mg Days 1-5 Ridaforolimus 40 mg administered orally once daily on Days 1-5 per week.
Overall Study Progressive disease	2	0	0	1	1
Overall Study Withdrawal by Subject	1	0	0	0	0

Baseline Characteristics

Extension Trial of Deforolimus (Ridaforolimus, MK-8669) in Participants With Advanced Cancer (MK-8669-038)

Baseline characteristics by cohort

Measure	Ridaforolimus 10 mg Days 1-5 n=3 Participants Ridaforolimus 10 mg administered orally once daily on Days 1-5 per week.	Ridaforolimus 10 mg Days 1-6 n=1 Participants Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week.	Ridaforolimus 20 mg Days 1-5 n=1 Participants Ridaforolimus 20 mg administered once daily on Days 1-5 per week.	Ridaforolimus 30 mg Days 1-5 n=1 Participants Ridaforolimus 30 mg administered orally once daily on Days 1-5 per week.	Ridaforolimus 40 mg Days 1-5 n=1 Participants Ridaforolimus 40 mg administered orally once daily on Days 1-5 per week.	Total n=7 Participants Total of all reporting groups
Age, Continuous	47.7 Years STANDARD_DEVIATION 15.0 • n=5 Participants	47.0 Years n=7 Participants	67.0 Years n=5 Participants	53.0 Years n=4 Participants	13.0 Years n=21 Participants	46.1 Years STANDARD_DEVIATION 18.4 • n=10 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	6 Participants n=10 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race/Ethnicity, Customized White	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	6 Participants n=10 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants

PRIMARY outcome

Timeframe: Up to approximately 2991 days, including 30 days after the last dose (through data cut-off date of 03 Apr 2017)

Population: All participants who received any study drug on this extension protocol according to their actual treatment.

An adverse event is defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a participant during a clinical study or the follow-up period, regardless of relationship to study drug. The number of participants who experienced an adverse event is presented.

Outcome measures

Measure	Ridaforolimus 10 mg Days 1-5 n=3 Participants Ridaforolimus 10 mg administered orally once daily on Days 1-5 per week.	Ridaforolimus 10 mg Days 1-6 n=1 Participants Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week.	Ridaforolimus 20 mg Days 1-5 n=1 Participants Ridaforolimus 20 mg administered once daily on Days 1-5 per week.	Ridaforolimus 30 mg Days 1-5 n=1 Participants Ridaforolimus 30 mg administered orally once daily on Days 1-5 per week.	Ridaforolimus 40 mg Days 1-5 n=1 Participants Ridaforolimus 40 mg administered orally once daily on Days 1-5 per week.
Number of Participants Who Experienced an Adverse Event	3 Participants	1 Participants	1 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: Up to approximately 2961 days (through data cut-off date of 03 Apr 2017)

Population: All participants who received any study drug on this extension protocol according to their actual treatment.

An adverse event is defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a participant during a clinical study or the follow-up period, regardless of relationship to study drug. The number of participants who discontinued study drug due to an adverse event is presented.

Outcome measures

Measure	Ridaforolimus 10 mg Days 1-5 n=3 Participants Ridaforolimus 10 mg administered orally once daily on Days 1-5 per week.	Ridaforolimus 10 mg Days 1-6 n=1 Participants Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week.	Ridaforolimus 20 mg Days 1-5 n=1 Participants Ridaforolimus 20 mg administered once daily on Days 1-5 per week.	Ridaforolimus 30 mg Days 1-5 n=1 Participants Ridaforolimus 30 mg administered orally once daily on Days 1-5 per week.	Ridaforolimus 40 mg Days 1-5 n=1 Participants Ridaforolimus 40 mg administered orally once daily on Days 1-5 per week.
Number of Participants Who Discontinued Study Drug Due to an Adverse Event	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to approximately 2961 days (through data cut-off date of 03 Apr 2017)

Population: All participants who received any study drug on this extension protocol according to their actual treatment.

PFS was defined as the time from randomization to the first documented progressive disease (PD), or death due to any cause, whichever occurred first. Per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1), PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS for all participants is presented in days.

Outcome measures

Measure	Ridaforolimus 10 mg Days 1-5 n=3 Participants Ridaforolimus 10 mg administered orally once daily on Days 1-5 per week.	Ridaforolimus 10 mg Days 1-6 n=1 Participants Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week.	Ridaforolimus 20 mg Days 1-5 n=1 Participants Ridaforolimus 20 mg administered once daily on Days 1-5 per week.	Ridaforolimus 30 mg Days 1-5 n=1 Participants Ridaforolimus 30 mg administered orally once daily on Days 1-5 per week.	Ridaforolimus 40 mg Days 1-5 n=1 Participants Ridaforolimus 40 mg administered orally once daily on Days 1-5 per week.
Progression-free Survival (PFS)	488.67 Days Interval 78.0 to 1297.0	2858 Days Interval 2858.0 to 2858.0	2936 Days Interval 2936.0 to 2936.0	1142 Days Interval 1142.0 to 1142.0	29 Days Interval 29.0 to 29.0

SECONDARY outcome

Timeframe: Up to approximately 2991 days (through data cut-off date of 03 Apr 2017)

Population: All participants who received any study drug on this extension protocol according to their actual treatment.

OS is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis will be censored at the date of the last follow-up.

Outcome measures

Measure	Ridaforolimus 10 mg Days 1-5 n=3 Participants Ridaforolimus 10 mg administered orally once daily on Days 1-5 per week.	Ridaforolimus 10 mg Days 1-6 n=1 Participants Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week.	Ridaforolimus 20 mg Days 1-5 n=1 Participants Ridaforolimus 20 mg administered once daily on Days 1-5 per week.	Ridaforolimus 30 mg Days 1-5 n=1 Participants Ridaforolimus 30 mg administered orally once daily on Days 1-5 per week.	Ridaforolimus 40 mg Days 1-5 n=1 Participants Ridaforolimus 40 mg administered orally once daily on Days 1-5 per week.
Overall Survival (OS)	1803.67 Days Interval 1067.0 to 2451.0	2933 Days Interval 2933.0 to 2933.0	2962 Days Interval 2962.0 to 2962.0	2334 Days Interval 2334.0 to 2334.0	247 Days Interval 247.0 to 247.0

SECONDARY outcome

Timeframe: Up to approximately 2961 days (through data cut-off date of 03 Apr 2017)

Population: All participants who received any study drug on this extension protocol according to their actual treatment and who experienced a CR or PR.

For participants who demonstrated a confirmed response (Completed Response [CR] or Partial Response [PR]) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment.

Outcome measures

Measure	Ridaforolimus 10 mg Days 1-5 Ridaforolimus 10 mg administered orally once daily on Days 1-5 per week.	Ridaforolimus 10 mg Days 1-6 Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week.	Ridaforolimus 20 mg Days 1-5 n=1 Participants Ridaforolimus 20 mg administered once daily on Days 1-5 per week.	Ridaforolimus 30 mg Days 1-5 Ridaforolimus 30 mg administered orally once daily on Days 1-5 per week.	Ridaforolimus 40 mg Days 1-5 Ridaforolimus 40 mg administered orally once daily on Days 1-5 per week.
Duration of Response (DOR)	—	—	2894 Days	—	—

Adverse Events

Ridaforolimus 10 mg Days 1-5 (Up to Data Cut-Off)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Ridaforolimus 10 mg Days 1-6 (Up to Data Cut-Off)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Ridaforolimus 20 mg Days 1-5 (Up to Data Cut-Off)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Ridaforolimus 30 mg Days 1-5 (Up to Data Cut-Off)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Ridaforolimus 40 mg Days 1-5 (Up to Data Cut-Off)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Ridaforolimus 10 mg Days 1-6 (Post Data Cut-Off)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ridaforolimus 20 mg Days 1-5 (Post Data Cut-Off)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ridaforolimus 10 mg Days 1-5 (Up to Data Cut-Off) n=3 participants at risk Ridaforolimus 10 mg administered orally once daily on Days 1-5 per week.	Ridaforolimus 10 mg Days 1-6 (Up to Data Cut-Off) n=1 participants at risk Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week.	Ridaforolimus 20 mg Days 1-5 (Up to Data Cut-Off) n=1 participants at risk Ridaforolimus 20 mg administered once daily on Days 1-5 per week.	Ridaforolimus 30 mg Days 1-5 (Up to Data Cut-Off) n=1 participants at risk Ridaforolimus 30 mg administered orally once daily on Days 1-5 per week.	Ridaforolimus 40 mg Days 1-5 (Up to Data Cut-Off) n=1 participants at risk Ridaforolimus 40 mg administered orally once daily on Days 1-5 per week.	Ridaforolimus 10 mg Days 1-6 (Post Data Cut-Off) n=1 participants at risk Participants remaining on treatment after closure of the study database. Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week.	Ridaforolimus 20 mg Days 1-5 (Post Data Cut-Off) n=1 participants at risk Participants remaining on treatment after closure of the study database. Ridaforolimus 20 mg administered orally once daily on Days 1-5 per week.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.

Other adverse events

Measure	Ridaforolimus 10 mg Days 1-5 (Up to Data Cut-Off) n=3 participants at risk Ridaforolimus 10 mg administered orally once daily on Days 1-5 per week.	Ridaforolimus 10 mg Days 1-6 (Up to Data Cut-Off) n=1 participants at risk Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week.	Ridaforolimus 20 mg Days 1-5 (Up to Data Cut-Off) n=1 participants at risk Ridaforolimus 20 mg administered once daily on Days 1-5 per week.	Ridaforolimus 30 mg Days 1-5 (Up to Data Cut-Off) n=1 participants at risk Ridaforolimus 30 mg administered orally once daily on Days 1-5 per week.	Ridaforolimus 40 mg Days 1-5 (Up to Data Cut-Off) n=1 participants at risk Ridaforolimus 40 mg administered orally once daily on Days 1-5 per week.	Ridaforolimus 10 mg Days 1-6 (Post Data Cut-Off) n=1 participants at risk Participants remaining on treatment after closure of the study database. Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week.	Ridaforolimus 20 mg Days 1-5 (Post Data Cut-Off) n=1 participants at risk Participants remaining on treatment after closure of the study database. Ridaforolimus 20 mg administered orally once daily on Days 1-5 per week.
Blood and lymphatic system disorders Anaemia	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 14 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Ear and labyrinth disorders Tinnitus	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Ear and labyrinth disorders Vertigo	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Ear and labyrinth disorders Vertigo positional	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Eye disorders Blepharospasm	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 2 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Eye disorders Cataract	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 2 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Eye disorders Vision blurred	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Gastrointestinal disorders Abdominal discomfort	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 2 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Gastrointestinal disorders Dental discomfort	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 5 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Gastrointestinal disorders Dyspepsia	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 2 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 2 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Gastrointestinal disorders Retching	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Gastrointestinal disorders Stomatitis	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 10 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Gastrointestinal disorders Toothache	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
General disorders Chest pain	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
General disorders Chills	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
General disorders Fatigue	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 2 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
General disorders Injection site haemorrhage	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Immune system disorders Hypersensitivity	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Immune system disorders Seasonal allergy	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Infections and infestations Bronchitis	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Infections and infestations Gastroenteritis	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Infections and infestations Hordeolum	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Infections and infestations Oral herpes	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Infections and infestations Pharyngitis	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Infections and infestations Tinea pedis	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Infections and infestations Tonsillitis	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Infections and infestations Upper respiratory tract infection	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Infections and infestations Urinary tract infection	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 2 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Infections and infestations Viral infection	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Injury, poisoning and procedural complications Post-traumatic pain	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Investigations Chest X-ray abnormal	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Investigations Weight decreased	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Metabolism and nutrition disorders Hyperglycaemia	33.3% 1/3 • Number of events 9 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Metabolism and nutrition disorders Hypertriglyceridaemia	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 2 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 5 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 11 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 2 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Musculoskeletal and connective tissue disorders Back pain	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	33.3% 1/3 • Number of events 2 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	66.7% 2/3 • Number of events 2 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Musculoskeletal and connective tissue disorders Tendonitis	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Nervous system disorders Dizziness	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 2 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Nervous system disorders Headache	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Nervous system disorders Hyperaesthesia	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Nervous system disorders Hypoaesthesia	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Nervous system disorders Migraine	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Nervous system disorders Neuropathy peripheral	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Nervous system disorders Paraesthesia	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Nervous system disorders Trigeminal neuralgia	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Psychiatric disorders Anxiety	33.3% 1/3 • Number of events 2 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Psychiatric disorders Depression	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Renal and urinary disorders Dysuria	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 2 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Renal and urinary disorders Hydronephrosis	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Renal and urinary disorders Pollakiuria	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Respiratory, thoracic and mediastinal disorders Cough	66.7% 2/3 • Number of events 2 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 4 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Respiratory, thoracic and mediastinal disorders Productive cough	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Skin and subcutaneous tissue disorders Dermatitis acneiform	33.3% 1/3 • Number of events 2 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Skin and subcutaneous tissue disorders Hyperhidrosis	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Skin and subcutaneous tissue disorders Rash	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	33.3% 1/3 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.
Vascular disorders Hypertension	0.00% 0/3 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	100.0% 1/1 • Number of events 1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	0.00% 0/1 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.	— 0/0 • Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee All unpublished information that the Sponsor gives to the Investigator shall be kept confidential and shall not be published or disclosed to a third party without the prior written consent of the Sponsor.
• Publication restrictions are in place

Restriction type: OTHER