Trial Outcomes & Findings for A Phase 1/2 Study to Evaluate MEDI4736 (NCT NCT01693562)

Last Updated: 2021-05-13

Results Overview

A DLT was defined as any Grade 3 or higher treatment-related toxicity that occurred during the DLT-evaluation period including any \>= Grade 3 colitis or \>= Grade 3 immune-related adverse event (irAE; AEs of immune nature in the absence of a clear alternative etiology) including rash, pruritus, or diarrhea that did not downgrade to =\< Grade 2 within 3 days after onset of the event despite maximal supportive care including systemic corticosteroids. The DLT-evaluation period for 0.1 to 10 mg/kg arms was from Day 1 to Day 28 of first dose and for 15 mg/kg arm was from Day 1 to Day 42 of first dose.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

1022 participants

Primary outcome timeframe

For MEDI4736 0.1 to MEDI4736 10 mg/kg arms: from Day 1 to Day 28 of first dose; for MEDI4736 15 mg/kg arm: from Day 1 to Day 42 of first dose

Results posted on

2021-05-13

Participant Flow

The study was conducted in Belgium, Canada, France, Germany, Italy, South Korea, Taiwan, United Kingdom, and the United States of America.

Participant milestones

Participant milestones
Measure	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 1 mg/kg Q2W) Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Exploration Durvalumab 20 mg/kg (Q4W) Participants received IV infusion of MEDI4736 20 mg/kg every 4 weeks (Q4W) in the dose-exploration phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W) Participants with squamous cell carcinoma of the head and neck (SCCHN) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion Non-SCCHN HPV Positive Cohort (MEDI4736 10 mg/kg Q2W) Participants with non-SCCHN human papilloma virus positive (Non-SCCHN HPV+) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with non-small-cell lung cancer (NSCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W) Participants with hepatocellular carcinoma (HCC Total) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W) Participants with advance cutaneous melanoma (ACM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UM Cohort (MEDI4736 10 mg/kg Q2W) Participants with uveal melanoma (UM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion OC Cohort (MEDI4736 10 mg/kg Q2W) Participants with ovarian cancer (OC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Escalation Phase STARTED	4	4	3	3	6	7	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Escalation Phase COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Escalation Phase NOT COMPLETED	4	4	3	3	6	7	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Exploration Phase STARTED	0	0	0	0	0	0	21	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Exploration Phase COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Exploration Phase NOT COMPLETED	0	0	0	0	0	0	21	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Expansion Phase STARTED	0	0	0	0	0	0	0	62	22	304	40	21	24	51	40	31	201	20	47	20	21	62	10
Expansion Phase COMPLETED	0	0	0	0	0	0	0	0	0	4	0	0	1	0	0	0	4	0	0	0	0	0	0
Expansion Phase NOT COMPLETED	0	0	0	0	0	0	0	62	22	300	40	21	23	51	40	31	197	20	47	20	21	62	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 1 mg/kg Q2W) Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Exploration Durvalumab 20 mg/kg (Q4W) Participants received IV infusion of MEDI4736 20 mg/kg every 4 weeks (Q4W) in the dose-exploration phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W) Participants with squamous cell carcinoma of the head and neck (SCCHN) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion Non-SCCHN HPV Positive Cohort (MEDI4736 10 mg/kg Q2W) Participants with non-SCCHN human papilloma virus positive (Non-SCCHN HPV+) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with non-small-cell lung cancer (NSCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W) Participants with hepatocellular carcinoma (HCC Total) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W) Participants with advance cutaneous melanoma (ACM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UM Cohort (MEDI4736 10 mg/kg Q2W) Participants with uveal melanoma (UM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion OC Cohort (MEDI4736 10 mg/kg Q2W) Participants with ovarian cancer (OC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Escalation Phase Withdrawal by Subject	0	1	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Escalation Phase Death	4	2	0	3	6	4	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Escalation Phase Lost to Follow-up	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Escalation Phase Other	0	0	2	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Exploration Phase Withdrawal by Subject	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Exploration Phase Death	0	0	0	0	0	0	17	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Exploration Phase Other	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Expansion Phase Withdrawal by Subject	0	0	0	0	0	0	0	16	2	54	2	2	3	5	16	7	40	4	8	3	1	8	1
Expansion Phase Death	0	0	0	0	0	0	0	42	17	208	30	8	19	42	23	23	128	16	36	16	17	35	7
Expansion Phase Lost to Follow-up	0	0	0	0	0	0	0	1	2	10	4	4	1	3	0	1	1	0	2	1	2	2	1
Expansion Phase Other	0	0	0	0	0	0	0	3	1	28	4	7	0	1	1	0	28	0	1	0	1	17	1

Baseline Characteristics

The data for this baseline measure is reported separately for each phase of the study.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=4 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=4 Participants Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 1 mg/kg Q2W) n=3 Participants Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) n=3 Participants Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) n=6 Participants Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) n=7 Participants Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Exploration Durvalumab 20 mg/kg (Q4W) n=21 Participants Participants received IV infusion of MEDI4736 20 mg/kg every 4 weeks (Q4W) in the dose-exploration phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W) n=62 Participants Participants with squamous cell carcinoma of the head and neck (SCCHN) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion Non-SCCHN HPV Positive Cohort (MEDI4736 10 mg/kg Q2W) n=22 Participants Participants with non-SCCHN human papilloma virus positive (Non-SCCHN HPV+) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W) n=304 Participants Participants with non-small-cell lung cancer (NSCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W) n=40 Participants Participants with hepatocellular carcinoma (HCC Total) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W) n=21 Participants Participants with advance cutaneous melanoma (ACM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UM Cohort (MEDI4736 10 mg/kg Q2W) n=24 Participants Participants with uveal melanoma (UM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) n=51 Participants Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) n=40 Participants Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) n=31 Participants Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) n=201 Participants Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) n=20 Participants Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion OC Cohort (MEDI4736 10 mg/kg Q2W) n=47 Participants Participants with ovarian cancer (OC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) n=20 Participants Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) n=21 Participants Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) n=62 Participants Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) n=10 Participants Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Total n=1024 Participants Total of all reporting groups
Age, Customized Escalation Phase · 18-64 years	2 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	2 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	6 Participants n=6 Participants • The data for this baseline measure is reported separately for each phase of the study.	4 Participants n=7 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	15 Participants n=27 Participants • The data for this baseline measure is reported separately for each phase of the study.
Age, Customized Escalation Phase · 65-84 years	2 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	4 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	2 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=6 Participants • The data for this baseline measure is reported separately for each phase of the study.	3 Participants n=7 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	12 Participants n=27 Participants • The data for this baseline measure is reported separately for each phase of the study.
Age, Customized Escalation Phase · 85 years and above	0 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=6 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=7 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=27 Participants • The data for this baseline measure is reported separately for each phase of the study.
Age, Customized Exploration Phase · 18-64 years	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	12 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	12 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.
Age, Customized Exploration Phase · 65-84 years	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	9 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	9 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.
Age, Customized Exploration Phase · 85 years and above	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.
Age, Customized Expansion Phase · 18-64 years	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	41 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	19 Participants n=22 Participants • The data for this baseline measure is reported separately for each phase of the study.	146 Participants n=304 Participants • The data for this baseline measure is reported separately for each phase of the study.	26 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	12 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	14 Participants n=24 Participants • The data for this baseline measure is reported separately for each phase of the study.	33 Participants n=51 Participants • The data for this baseline measure is reported separately for each phase of the study.	35 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	16 Participants n=31 Participants • The data for this baseline measure is reported separately for each phase of the study.	77 Participants n=201 Participants • The data for this baseline measure is reported separately for each phase of the study.	16 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	30 Participants n=47 Participants • The data for this baseline measure is reported separately for each phase of the study.	15 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	9 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	47 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	7 Participants n=10 Participants • The data for this baseline measure is reported separately for each phase of the study.	543 Participants n=976 Participants • The data for this baseline measure is reported separately for each phase of the study.
Age, Customized Expansion Phase · 65-84 years	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	20 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	3 Participants n=22 Participants • The data for this baseline measure is reported separately for each phase of the study.	156 Participants n=304 Participants • The data for this baseline measure is reported separately for each phase of the study.	14 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	9 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	10 Participants n=24 Participants • The data for this baseline measure is reported separately for each phase of the study.	18 Participants n=51 Participants • The data for this baseline measure is reported separately for each phase of the study.	5 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	15 Participants n=31 Participants • The data for this baseline measure is reported separately for each phase of the study.	122 Participants n=201 Participants • The data for this baseline measure is reported separately for each phase of the study.	4 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	16 Participants n=47 Participants • The data for this baseline measure is reported separately for each phase of the study.	5 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	12 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	15 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	3 Participants n=10 Participants • The data for this baseline measure is reported separately for each phase of the study.	427 Participants n=976 Participants • The data for this baseline measure is reported separately for each phase of the study.
Age, Customized Expansion Phase · 85 years and above	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=22 Participants • The data for this baseline measure is reported separately for each phase of the study.	2 Participants n=304 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=24 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=51 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=31 Participants • The data for this baseline measure is reported separately for each phase of the study.	2 Participants n=201 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=47 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=10 Participants • The data for this baseline measure is reported separately for each phase of the study.	6 Participants n=976 Participants • The data for this baseline measure is reported separately for each phase of the study.
Sex: Female, Male Escalation Phase · Female	2 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	2 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	2 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	2 Participants n=6 Participants • The data for this baseline measure is reported separately for each phase of the study.	2 Participants n=7 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	11 Participants n=27 Participants • The data for this baseline measure is reported separately for each phase of the study.
Sex: Female, Male Escalation Phase · Male	2 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	3 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	4 Participants n=6 Participants • The data for this baseline measure is reported separately for each phase of the study.	5 Participants n=7 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	16 Participants n=27 Participants • The data for this baseline measure is reported separately for each phase of the study.
Sex: Female, Male Exploration Phase · Female	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	5 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	5 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.
Sex: Female, Male Exploration Phase · Male	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	16 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	16 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.
Sex: Female, Male Expansion Phase · Female	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	9 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	15 Participants n=22 Participants • The data for this baseline measure is reported separately for each phase of the study.	133 Participants n=304 Participants • The data for this baseline measure is reported separately for each phase of the study.	8 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	9 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	10 Participants n=24 Participants • The data for this baseline measure is reported separately for each phase of the study.	13 Participants n=51 Participants • The data for this baseline measure is reported separately for each phase of the study.	40 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	9 Participants n=31 Participants • The data for this baseline measure is reported separately for each phase of the study.	58 Participants n=201 Participants • The data for this baseline measure is reported separately for each phase of the study.	7 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	47 Participants n=47 Participants • The data for this baseline measure is reported separately for each phase of the study.	15 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	8 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	34 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	3 Participants n=10 Participants • The data for this baseline measure is reported separately for each phase of the study.	418 Participants n=976 Participants • The data for this baseline measure is reported separately for each phase of the study.
Sex: Female, Male Expansion Phase · Male	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	53 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	7 Participants n=22 Participants • The data for this baseline measure is reported separately for each phase of the study.	171 Participants n=304 Participants • The data for this baseline measure is reported separately for each phase of the study.	32 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	12 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	14 Participants n=24 Participants • The data for this baseline measure is reported separately for each phase of the study.	38 Participants n=51 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	22 Participants n=31 Participants • The data for this baseline measure is reported separately for each phase of the study.	143 Participants n=201 Participants • The data for this baseline measure is reported separately for each phase of the study.	13 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=47 Participants • The data for this baseline measure is reported separately for each phase of the study.	5 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	13 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	28 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	7 Participants n=10 Participants • The data for this baseline measure is reported separately for each phase of the study.	558 Participants n=976 Participants • The data for this baseline measure is reported separately for each phase of the study.
Ethnicity (NIH/OMB) Escalation Phase · Hispanic or Latino	1 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=6 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=7 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	3 Participants n=27 Participants • The data for this baseline measure is reported separately for each phase of the study.
Ethnicity (NIH/OMB) Escalation Phase · Not Hispanic or Latino	3 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	4 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	2 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	3 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	5 Participants n=6 Participants • The data for this baseline measure is reported separately for each phase of the study.	6 Participants n=7 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	23 Participants n=27 Participants • The data for this baseline measure is reported separately for each phase of the study.
Ethnicity (NIH/OMB) Escalation Phase · Unknown or Not Reported	0 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=6 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=7 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=27 Participants • The data for this baseline measure is reported separately for each phase of the study.
Ethnicity (NIH/OMB) Exploration Phase · Hispanic or Latino	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	2 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	2 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.
Ethnicity (NIH/OMB) Exploration Phase · Not Hispanic or Latino	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	19 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	19 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.
Ethnicity (NIH/OMB) Exploration Phase · Unknown or Not Reported	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.
Ethnicity (NIH/OMB) Expansion Phase · Hispanic or Latino	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	5 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=22 Participants • The data for this baseline measure is reported separately for each phase of the study.	12 Participants n=304 Participants • The data for this baseline measure is reported separately for each phase of the study.	2 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	2 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=24 Participants • The data for this baseline measure is reported separately for each phase of the study.	4 Participants n=51 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=31 Participants • The data for this baseline measure is reported separately for each phase of the study.	5 Participants n=201 Participants • The data for this baseline measure is reported separately for each phase of the study.	2 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	2 Participants n=47 Participants • The data for this baseline measure is reported separately for each phase of the study.	5 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	4 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=10 Participants • The data for this baseline measure is reported separately for each phase of the study.	47 Participants n=976 Participants • The data for this baseline measure is reported separately for each phase of the study.
Ethnicity (NIH/OMB) Expansion Phase · Not Hispanic or Latino	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	54 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	21 Participants n=22 Participants • The data for this baseline measure is reported separately for each phase of the study.	287 Participants n=304 Participants • The data for this baseline measure is reported separately for each phase of the study.	32 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	19 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	18 Participants n=24 Participants • The data for this baseline measure is reported separately for each phase of the study.	43 Participants n=51 Participants • The data for this baseline measure is reported separately for each phase of the study.	33 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	30 Participants n=31 Participants • The data for this baseline measure is reported separately for each phase of the study.	177 Participants n=201 Participants • The data for this baseline measure is reported separately for each phase of the study.	18 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	39 Participants n=47 Participants • The data for this baseline measure is reported separately for each phase of the study.	15 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	20 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	42 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	10 Participants n=10 Participants • The data for this baseline measure is reported separately for each phase of the study.	858 Participants n=976 Participants • The data for this baseline measure is reported separately for each phase of the study.
Ethnicity (NIH/OMB) Expansion Phase · Unknown or Not Reported	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	3 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=22 Participants • The data for this baseline measure is reported separately for each phase of the study.	5 Participants n=304 Participants • The data for this baseline measure is reported separately for each phase of the study.	6 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	5 Participants n=24 Participants • The data for this baseline measure is reported separately for each phase of the study.	4 Participants n=51 Participants • The data for this baseline measure is reported separately for each phase of the study.	7 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=31 Participants • The data for this baseline measure is reported separately for each phase of the study.	19 Participants n=201 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	6 Participants n=47 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	16 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=10 Participants • The data for this baseline measure is reported separately for each phase of the study.	71 Participants n=976 Participants • The data for this baseline measure is reported separately for each phase of the study.
Race/Ethnicity, Customized Escalation Phase · American Indian or Alaskan Native	0 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=6 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=7 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=27 Participants • The data for this baseline measure is reported separately for each phase of the study.
Race/Ethnicity, Customized Escalation Phase · Asian	0 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=6 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=7 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=27 Participants • The data for this baseline measure is reported separately for each phase of the study.
Race/Ethnicity, Customized Escalation Phase · Black or African American	0 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=6 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=7 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=27 Participants • The data for this baseline measure is reported separately for each phase of the study.
Race/Ethnicity, Customized Escalation Phase · Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=6 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=7 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=27 Participants • The data for this baseline measure is reported separately for each phase of the study.
Race/Ethnicity, Customized Escalation Phase · White	4 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	3 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	2 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	2 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	6 Participants n=6 Participants • The data for this baseline measure is reported separately for each phase of the study.	7 Participants n=7 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	24 Participants n=27 Participants • The data for this baseline measure is reported separately for each phase of the study.
Race/Ethnicity, Customized Escalation Phase · Other	0 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=6 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=7 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=27 Participants • The data for this baseline measure is reported separately for each phase of the study.
Race/Ethnicity, Customized Escalation Phase · Multiple	0 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=6 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=7 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=27 Participants • The data for this baseline measure is reported separately for each phase of the study.
Race/Ethnicity, Customized Escalation Phase · Missing	0 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=4 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=3 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=6 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=7 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=27 Participants • The data for this baseline measure is reported separately for each phase of the study.
Race/Ethnicity, Customized Exploration Phase · American Indian or Alaskan Native	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.
Race/Ethnicity, Customized Exploration Phase · Asian	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.
Race/Ethnicity, Customized Exploration Phase · Black or African American	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.
Race/Ethnicity, Customized Exploration Phase · Native Hawaiian or Other Pacific Islander	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.
Race/Ethnicity, Customized Exploration Phase · White	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	19 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	19 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.
Race/Ethnicity, Customized Exploration Phase · Other	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.
Race/Ethnicity, Customized Exploration Phase · Multiple	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.
Race/Ethnicity, Customized Exploration Phase · Missing	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.
Race/Ethnicity, Customized Expansion Phase · American Indian or Alaskan Native	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=22 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=304 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=24 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=51 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=31 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=201 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=47 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=10 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=976 Participants • The data for this baseline measure is reported separately for each phase of the study.
Race/Ethnicity, Customized Expansion Phase · Asian	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	5 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=22 Participants • The data for this baseline measure is reported separately for each phase of the study.	58 Participants n=304 Participants • The data for this baseline measure is reported separately for each phase of the study.	9 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=24 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=51 Participants • The data for this baseline measure is reported separately for each phase of the study.	2 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=31 Participants • The data for this baseline measure is reported separately for each phase of the study.	40 Participants n=201 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	4 Participants n=47 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	2 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	6 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	5 Participants n=10 Participants • The data for this baseline measure is reported separately for each phase of the study.	134 Participants n=976 Participants • The data for this baseline measure is reported separately for each phase of the study.
Race/Ethnicity, Customized Expansion Phase · Black or African American	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	2 Participants n=22 Participants • The data for this baseline measure is reported separately for each phase of the study.	10 Participants n=304 Participants • The data for this baseline measure is reported separately for each phase of the study.	3 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=24 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=51 Participants • The data for this baseline measure is reported separately for each phase of the study.	6 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=31 Participants • The data for this baseline measure is reported separately for each phase of the study.	8 Participants n=201 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=47 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	2 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=10 Participants • The data for this baseline measure is reported separately for each phase of the study.	38 Participants n=976 Participants • The data for this baseline measure is reported separately for each phase of the study.
Race/Ethnicity, Customized Expansion Phase · Native Hawaiian or Other Pacific Islander	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=22 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=304 Participants • The data for this baseline measure is reported separately for each phase of the study.	2 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=24 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=51 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=31 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=201 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=47 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	2 Participants n=10 Participants • The data for this baseline measure is reported separately for each phase of the study.	5 Participants n=976 Participants • The data for this baseline measure is reported separately for each phase of the study.
Race/Ethnicity, Customized Expansion Phase · White	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	49 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	19 Participants n=22 Participants • The data for this baseline measure is reported separately for each phase of the study.	227 Participants n=304 Participants • The data for this baseline measure is reported separately for each phase of the study.	19 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	19 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	19 Participants n=24 Participants • The data for this baseline measure is reported separately for each phase of the study.	45 Participants n=51 Participants • The data for this baseline measure is reported separately for each phase of the study.	25 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	29 Participants n=31 Participants • The data for this baseline measure is reported separately for each phase of the study.	128 Participants n=201 Participants • The data for this baseline measure is reported separately for each phase of the study.	19 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	36 Participants n=47 Participants • The data for this baseline measure is reported separately for each phase of the study.	18 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	17 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	34 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	3 Participants n=10 Participants • The data for this baseline measure is reported separately for each phase of the study.	706 Participants n=976 Participants • The data for this baseline measure is reported separately for each phase of the study.
Race/Ethnicity, Customized Expansion Phase · Other	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	2 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=22 Participants • The data for this baseline measure is reported separately for each phase of the study.	4 Participants n=304 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=24 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=51 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=31 Participants • The data for this baseline measure is reported separately for each phase of the study.	5 Participants n=201 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=47 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	4 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=10 Participants • The data for this baseline measure is reported separately for each phase of the study.	20 Participants n=976 Participants • The data for this baseline measure is reported separately for each phase of the study.
Race/Ethnicity, Customized Expansion Phase · Multiple	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=22 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=304 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=24 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=51 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=31 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=201 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=47 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=10 Participants • The data for this baseline measure is reported separately for each phase of the study.	2 Participants n=976 Participants • The data for this baseline measure is reported separately for each phase of the study.
Race/Ethnicity, Customized Expansion Phase · Missing	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	0 Participants The data for this baseline measure is reported separately for each phase of the study.	4 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=22 Participants • The data for this baseline measure is reported separately for each phase of the study.	5 Participants n=304 Participants • The data for this baseline measure is reported separately for each phase of the study.	6 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	1 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	5 Participants n=24 Participants • The data for this baseline measure is reported separately for each phase of the study.	3 Participants n=51 Participants • The data for this baseline measure is reported separately for each phase of the study.	6 Participants n=40 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=31 Participants • The data for this baseline measure is reported separately for each phase of the study.	19 Participants n=201 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	6 Participants n=47 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=20 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=21 Participants • The data for this baseline measure is reported separately for each phase of the study.	16 Participants n=62 Participants • The data for this baseline measure is reported separately for each phase of the study.	0 Participants n=10 Participants • The data for this baseline measure is reported separately for each phase of the study.	71 Participants n=976 Participants • The data for this baseline measure is reported separately for each phase of the study.

PRIMARY outcome

Timeframe: For MEDI4736 0.1 to MEDI4736 10 mg/kg arms: from Day 1 to Day 28 of first dose; for MEDI4736 15 mg/kg arm: from Day 1 to Day 42 of first dose

Population: DLT-evaluable population included all participants in the dose-escalation phase who received at least 2 doses of study drug and completed safety follow-up through DLT-evaluable period or experienced any DLT during the DLT-evaluation period.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=4 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=4 Participants Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) n=3 Participants Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) n=3 Participants Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) n=6 Participants Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) n=7 Participants Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Number of Participants With Dose-limiting Toxicities in the Dose-escalation Phase	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)

Population: As-treated population included all participants who received any dose of study drug. Participants enrolled in the 10 mg/kg Q2W Expansion and Escalation Cohort have been summarized as a total only. This is because the safety profile of durvalumab monotherapy 10 mg/kg Q2W was manageable and generally consistent with the known safety profile of the anti-programmed cell death ligand (PD-L1/PD-1) drug class.

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=4 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=4 Participants Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) n=3 Participants Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) n=3 Participants Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) n=7 Participants Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) n=21 Participants Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) n=980 Participants Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Any TEAEs	—	—	—	3 Participants	4 Participants	3 Participants	3 Participants	7 Participants	21 Participants	963 Participants	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Any TESAEs	—	—	—	1 Participants	2 Participants	1 Participants	1 Participants	3 Participants	13 Participants	536 Participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)

Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of coagulation, urine, hematology, and serum chemistry.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=4 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=4 Participants Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) n=3 Participants Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) n=3 Participants Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) n=7 Participants Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) n=21 Participants Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) n=980 Participants Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Haemoglobin decreased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Hypophosphataemia	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	16 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Hypocalcaemia	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	17 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Iron deficiency anaemia	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Anaemia	—	—	—	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	166 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Thrombocytopenia	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	24 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase White blood cell count increased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Leukocytosis	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	20 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Lymphocyte count decreased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	12 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Neutropenia	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	8 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Leukopenia	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	7 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Thrombocytosis	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	5 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Neutrophil count increased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Red blood cell count decreased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Anaemia of chronic disease	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Eosinophilia	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Haemolysis	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Leukostasis syndrome	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Immune thrombocytopenic purpura	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase International normalised ratio increased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	16 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Hypokalaemia	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	60 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Activated partial thromboplastin time prolonged	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	15 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Blood fibrinogen increased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	8 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Platelet count decreased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	5 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Disseminated intravascular coagulation	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Prothrombin time prolonged	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Activated partial thromboplastin time shortened	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Coagulation factor increased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Coagulopathy	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Alanine aminotransferase increased	—	—	—	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants	77 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Aspartate aminotransferase increased	—	—	—	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants	99 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Blood alkaline phosphatase increased	—	—	—	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	70 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Blood bilirubin increased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	42 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Gamma-glutamyltransferase increased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	71 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Hyperbilirubinaemia	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	14 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Transaminases increased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	8 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Blood lactate dehydrogenase increased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	7 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Hepatic function abnormal	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	6 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Alanine aminotransferase decreased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Aspartate aminotransferase decreased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Blood albumin decreased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Hepatic enzyme increased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Liver function test increased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase White blood cell count decreased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	8 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Neutrophil count decreased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	5 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Lymphopenia	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	5 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Blood creatinine increased	—	—	—	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	46 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Hyperuricaemia	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	22 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Blood urea increased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	10 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Glomerular filtration rate decreased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Hypothyroidism	—	—	—	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	3 Participants	89 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Hyperthyroidism	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	30 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Blood thyroid stimulating hormone increased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	16 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Blood thyroid stimulating hormone decreased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	5 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Thyroxine decreased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Thyroxine free decreased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Thyroxine free increased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Tri-iodothyronine free decreased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Thyroxine increased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Tri-iodothyronine decreased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Tri-iodothyronine increased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Hyponatraemia	—	—	—	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	91 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Hypomagnesaemia	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	55 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Hypercalcaemia	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	47 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Hyperglycaemia	—	—	—	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	32 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Hypertriglyceridaemia	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	13 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Hypoglycaemia	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	10 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Blood cholesterol increased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	6 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Blood magnesium decreased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	5 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Blood triglycerides increased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	5 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Blood glucose increased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	4 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Hypercholesterolaemia	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	4 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Blood potassium increased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Blood chloride increased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Blood electrolytes decreased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Blood potassium decreased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Hyperphosphataemia	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Protein total decreased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Protein urine present	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Blood bicarbonate decreased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Blood chloride decreased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Blood sodium decreased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Hypermagnesaemia	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Hypernatraemia	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Hypochloraemia	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Hypoproteinaemia	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Hyperkalaemia	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	30 Participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)

Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (body weight, body temperature, blood pressure, pulse rate, and respiratory rate).

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=4 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=4 Participants Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) n=3 Participants Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) n=3 Participants Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) n=7 Participants Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) n=21 Participants Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) n=980 Participants Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Number of Participants With Abnormal Vital Signs Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Tachycardia	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	19 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Vital Signs Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Pyrexia	—	—	—	0 Participants	3 Participants	0 Participants	1 Participants	3 Participants	2 Participants	145 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Vital Signs Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Weight decreased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	79 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Vital Signs Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Hypertension	—	—	—	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	31 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Vital Signs Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Hypotension	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	36 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Vital Signs Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Weight increased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	22 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Vital Signs Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Sinus tachycardia	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	14 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Vital Signs Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Arrhythmia	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Vital Signs Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Sinus bradycardia	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Vital Signs Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Heart rate increased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Vital Signs Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Heart rate irregular	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—
Number of Participants With Abnormal Vital Signs Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Peak expiratory flow rate decreased	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From Baseline (Day 1) through 90 days after the last dose of study drug (approximately 5.25 years)

Population: As-treated population included all participants who received any dose of study drug were analyzed. Participants with ECG readings available were evaluable for this analysis. Participants enrolled in the 10 mg/kg Q2W Expansion and Escalation Cohort have been summarized as a total only. This is because the safety profile of durvalumab monotherapy 10 mg/kg Q2W was manageable and generally consistent with the known safety profile of the anti-PD-L1/PD-1 drug class.

Number of participants with change from baseline in notable QT/QTc interval in local electrocardiogram (ECG) are reported. The data for \>0 participants with notable QT/QTc interval in local ECG from baseline are reported.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=4 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=4 Participants Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) n=3 Participants Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) n=3 Participants Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) n=7 Participants Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) n=21 Participants Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) n=980 Participants Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Number of Participants With Change From Baseline in QT/QTc Interval in Local Electrocardiogram in the Dose-escalation, Dose-exploration, and Dose-expansion Phase QTcF: > 30 (msec)	—	—	—	—	1 Participants	0 Participants	0 Participants	—	—	4 Participants	—	—	—	—	—	—	—
Number of Participants With Change From Baseline in QT/QTc Interval in Local Electrocardiogram in the Dose-escalation, Dose-exploration, and Dose-expansion Phase QTcF: > 60 (msec)	—	—	—	—	1 Participants	0 Participants	0 Participants	—	—	0 Participants	—	—	—	—	—	—	—
Number of Participants With Change From Baseline in QT/QTc Interval in Local Electrocardiogram in the Dose-escalation, Dose-exploration, and Dose-expansion Phase QTcB: > 30 (msec)	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	4 Participants	17 Participants	—	—	—	—	—	—	—
Number of Participants With Change From Baseline in QT/QTc Interval in Local Electrocardiogram in the Dose-escalation, Dose-exploration, and Dose-expansion Phase QTcB: > 60 (msec)	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	4 Participants	—	—	—	—	—	—	—
Number of Participants With Change From Baseline in QT/QTc Interval in Local Electrocardiogram in the Dose-escalation, Dose-exploration, and Dose-expansion Phase QTcB: > 90 (msec)	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Population: Participants with non-squamous NSCLC in Full analysis set (FAS) population who had received 2 or more prior line of therapy were analyzed. FAS population included all participants who received any dose of study drug, had measurable disease at baseline (Day 1) per BICR and were followed for at least 24 weeks by 16Oct2017.

The ORR assessed by BICR in participants with non-squamous NSCLC who had received 2 or more prior lines of therapy is reported. The ORR is defined as best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1). The CR is defined as disappearance of all target and non-target lesions and no new lesions. A confirmed CR is defined as two CRs that were separated by at least 28 days with no evidence of progression in-between. The PR is defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an un-confirmed CR that were separated by at least 4 weeks with no evidence of progression in-between.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=68 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) in Participants With Non-squamous NSCLC Who Had Received 2 or More Prior Lines of Therapy in the Dose-expansion Phase	—	—	—	10.3 Percentage of participants Interval 4.2 to 20.1	—	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Population: Participants with squamous NSCLC in FAS population who had received 1 and 2 or more prior lines of therapy were analyzed. FAS population included all participants who received any dose of study drug, had measurable disease at baseline (Day 1) per BICR and were followed for at least 24 weeks by 16Oct2017.

The ORR assessed by BICR in participants with squamous NSCLC who had received 1 and 2 or more prior lines of therapy is reported. The ORR is defined as BOR of confirmed CR or confirmed PR based on RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. A confirmed CR is defined as two CRs that were separated by at least 28 days with no evidence of progression in-between. The PR is defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an un-confirmed CR that were separated by at least 4 weeks with no evidence of progression in-between.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=117 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=62 Participants Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
ORR Assessed by BICR in Participants With Squamous NSCLC Who Had Received 1 and 2 or More Prior Lines of Therapy in the Dose-expansion Phase	—	—	—	12.8 Percentage of participants Interval 7.4 to 20.3	12.9 Percentage of participants Interval 5.7 to 23.9	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Population: Participants with UC in FAS population with 2L+ post-platinum PD-L1 status high (\>= 25% tumor cell membrane or \>= 25% immune cell staining) were analyzed. FAS population included all participants who received any dose of study drug, had measurable disease at baseline (Day 1) per BICR and were followed for at least 24 weeks by 16Oct2017.

The ORR assessed by BICR in participants with UC post-platinum PD-L1 status high 2L+ is reported. The ORR is defined as BOR of confirmed CR or confirmed PR based on RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. A confirmed CR is defined as two CRs that were separated by at least 28 days with no evidence of progression in-between. The PR is defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an un-confirmed CR that were separated by at least 4 weeks with no evidence of progression in-between.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=98 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
ORR Assessed by BICR in Participants With UC Post-platinum (Programmed Cell Death Ligand [PD-L1] Status High) Who Had Received at Least 1 Line of Prior Therapy (2L+) in the Dose-expansion Phase	—	—	—	27.6 Percentage of participants Interval 19.0 to 37.5	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: After the first dose between Day 0 and Day 15 (Day 1 [pre and post dose] and predose of Dose 2 for all cohorts; Days 3, 5, 10 for Cohorts 0.1mg/kg to 10 mg/kg; Days 3, 5, 10, 15 for Cohort 15 mg/kg; Day 15 for Cohort 20 mg/kg)

Population: Pharmacokinetics (PK) evaluable population included all participants who received any dose of study drug and had at least one postdose PK concentration. Non-compartmental PK analysis was conducted using the data from dose escalation and exploration phases only. The "Number of participants Analyzed" denotes the number of participants evaluated for this outcome measure.

Area under the concentration-time curve from time zero to the last measurable concentration (AUClast) of MEDI4736 is reported.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=4 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=4 Participants Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) n=3 Participants Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) n=3 Participants Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) n=5 Participants Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) n=7 Participants Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) n=18 Participants Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Area Under the Serum Concentration-time Curve up to the Last Measurable Concentration (AUClast) of MEDI4736 After the First Dose in the Dose-escalation and Dose-exploration Phase	—	—	—	5.144 Day*µg/mL Geometric Coefficient of Variation 45.1	25.063 Day*µg/mL Geometric Coefficient of Variation 65.5	130.546 Day*µg/mL Geometric Coefficient of Variation 20.1	399.863 Day*µg/mL Geometric Coefficient of Variation 21.7	1780.152 Day*µg/mL Geometric Coefficient of Variation 39.1	2943.770 Day*µg/mL Geometric Coefficient of Variation 36.3	4501.888 Day*µg/mL Geometric Coefficient of Variation 23.1	—	—	—	—	—	—	—

SECONDARY outcome

Population: The PK evaluable population included all participants who received any dose of study drug and had at least one postdose PK concentration. Non-compartmental PK analysis was conducted using the data from dose escalation and exploration phases only. The "Number of participants Analyzed" denotes the number of participants evaluated for this outcome measure.

The Cmax of MEDI4736 is reported.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=4 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=4 Participants Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) n=3 Participants Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) n=3 Participants Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) n=5 Participants Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) n=7 Participants Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) n=18 Participants Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Maximum Serum Concentration (Cmax) of MEDI4736 After the First Dose in the Dose-escalation and Dose-exploration Phase	—	—	—	2.780 µg/mL Geometric Coefficient of Variation 22.1	7.969 µg/mL Geometric Coefficient of Variation 23.0	22.773 µg/mL Geometric Coefficient of Variation 11.3	70.807 µg/mL Geometric Coefficient of Variation 17.0	293.540 µg/mL Geometric Coefficient of Variation 23.4	427.085 µg/mL Geometric Coefficient of Variation 25.5	416.051 µg/mL Geometric Coefficient of Variation 23.9	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Escalation: Day1 of Dose(D)1 & D3, even numbered doses after D4; Exploration: Day1 of D1 & D2, even numbered doses after D2; Expansion: Day1 of D1, every 12 weeks since D3; all phases: till EOT, 30 days and 3 and 6 months post last dose (~5.25 years)

Population: The ADA evaluable population included all participants who received any dose of study drug, had non-missing baseline (before Day 1) ADA, and at least one non-missing post-baseline ADA results. The "Number of participants Analyzed" denotes the number of participants evaluated for this outcome measure.

Number of participants with positive ADA titer to MEDI4736 are reported. Treatment-boosted ADA is defined as baseline positive ADA titer that was boosted to a 4-fold or higher level following drug administration; persistent positive is defined as positive at \>= 2 post-baseline assessments (with \>= 16 weeks between first and last positive) or positive at last post-baseline assessment; and transient positive is defined as having at least one post-baseline ADA-positive assessment and not fulfilling the condition of persistent positive.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) n=41 Participants Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) n=19 Participants Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) n=15 Participants Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=45 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=56 Participants Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) n=17 Participants Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) n=257 Participants Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) n=37 Participants Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) n=17 Participants Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) n=21 Participants Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) n=38 Participants Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) n=33 Participants Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) n=26 Participants Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) n=148 Participants Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) n=17 Participants Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) n=58 Participants Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) n=6 Participants Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI4736 in the Dose-escalation, Dose-exploration Phase, and Dose-expansion Phase. Transient positive	2 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI4736 in the Dose-escalation, Dose-exploration Phase, and Dose-expansion Phase. Positive post-baseline	2 Participants	1 Participants	0 Participants	4 Participants	1 Participants	0 Participants	6 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	7 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI4736 in the Dose-escalation, Dose-exploration Phase, and Dose-expansion Phase. Treatment-boosted	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI4736 in the Dose-escalation, Dose-exploration Phase, and Dose-expansion Phase. Persistent positive	0 Participants	1 Participants	0 Participants	2 Participants	1 Participants	0 Participants	4 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	5 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Population: Participants in FAS population with NSCLC and SCCHN were analyzed. FAS population included all participants who received any dose of study drug, had measurable disease at baseline (Day 1) per BICR and were followed for at least 24 weeks by 16Oct2017.

The BOR assessed by BICR based on RECIST v1.1 in NSCLC and SCCHN cohorts is reported. The BOR includes CR, PR, stable disease (SD), progressive disease (PD), and non-evaluable (NE). The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. The PD is defined at least 20% increase in the sum of diameters of target lesions (compared to baseline) and/or new lesion. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. The NE is defined as either when no or only a subset of lesion measurements are made at an assessment.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=55 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=275 Participants Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Number of Participants With Best Overall Response (BOR) Assessed by BICR in NSCLC and SCCHN Cohort in the Dose-expansion Phase CR	—	—	—	0 Participants	3 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Best Overall Response (BOR) Assessed by BICR in NSCLC and SCCHN Cohort in the Dose-expansion Phase PR	—	—	—	4 Participants	39 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Best Overall Response (BOR) Assessed by BICR in NSCLC and SCCHN Cohort in the Dose-expansion Phase SD	—	—	—	10 Participants	80 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Best Overall Response (BOR) Assessed by BICR in NSCLC and SCCHN Cohort in the Dose-expansion Phase PD	—	—	—	31 Participants	110 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Best Overall Response (BOR) Assessed by BICR in NSCLC and SCCHN Cohort in the Dose-expansion Phase NE	—	—	—	10 Participants	43 Participants	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Population: As-treated population included all participants who received any dose of study drug. The "Number of participants Analyzed" denotes the number of participants evaluated for this outcome measure. One participant from non-SCCHN HPV positive cohort had non-evaluable disease at baseline.

The BOR assessed by investigator based on RECIST v1.1 is reported. The BOR includes CR, PR, SD, PD, and NE. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. The PD is defined at least 20% increase in the sum of diameters of target lesions (compared to baseline) and/or new lesion. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. The NE is defined as either when no or only a subset of lesion measurements are made at an assessment.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) n=47 Participants Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) n=20 Participants Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) n=21 Participants Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=48 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=62 Participants Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) n=22 Participants Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) n=302 Participants Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) n=40 Participants Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) n=21 Participants Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) n=24 Participants Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) n=51 Participants Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) n=40 Participants Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) n=31 Participants Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) n=201 Participants Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) n=20 Participants Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) n=62 Participants Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) n=10 Participants Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Number of Participants With BOR Assessed by Investigator in the Dose-escalation, Dose-exploration, and Dose-expansion Phase CR	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	5 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	18 Participants	0 Participants	3 Participants	0 Participants
Number of Participants With BOR Assessed by Investigator in the Dose-escalation, Dose-exploration, and Dose-expansion Phase PR	2 Participants	2 Participants	2 Participants	4 Participants	6 Participants	2 Participants	49 Participants	4 Participants	2 Participants	1 Participants	1 Participants	1 Participants	1 Participants	24 Participants	0 Participants	12 Participants	3 Participants
Number of Participants With BOR Assessed by Investigator in the Dose-escalation, Dose-exploration, and Dose-expansion Phase SD	18 Participants	8 Participants	4 Participants	18 Participants	14 Participants	7 Participants	102 Participants	22 Participants	9 Participants	8 Participants	17 Participants	8 Participants	6 Participants	45 Participants	5 Participants	27 Participants	2 Participants
Number of Participants With BOR Assessed by Investigator in the Dose-escalation, Dose-exploration, and Dose-expansion Phase PD	22 Participants	8 Participants	9 Participants	18 Participants	33 Participants	9 Participants	103 Participants	12 Participants	5 Participants	12 Participants	21 Participants	25 Participants	17 Participants	81 Participants	14 Participants	15 Participants	3 Participants
Number of Participants With BOR Assessed by Investigator in the Dose-escalation, Dose-exploration, and Dose-expansion Phase NE	4 Participants	2 Participants	6 Participants	7 Participants	8 Participants	2 Participants	43 Participants	2 Participants	4 Participants	3 Participants	11 Participants	6 Participants	7 Participants	33 Participants	1 Participants	5 Participants	2 Participants
Number of Participants With BOR Assessed by Investigator in the Dose-escalation, Dose-exploration, and Dose-expansion Phase Not applicable	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

The DoR assessed by BICR in NSCLC and SCCHN cohorts is reported. The DoR is defined as the duration from the first documentation of objective response (OR) (confirmed CR or confirmed PR) to the first documented disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 28 days with no evidence of progression in-between. A confirmed PR is defined as two PRs (\>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) or an un-confirmed PR and an un-confirmed CR that were separated by at least 4 weeks with no evidence of progression in-between. The DoR was estimated using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=4 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=42 Participants Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Duration of Response (DoR) Assessed by BICR in NSCLC and SCCHN Cohort in the Dose-expansion Phase	—	—	—	12.37 Months Interval 3.5 to Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	17.74 Months Interval 5.6 to 38.0	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Population: As-treated population included all participants who received any dose of study drug. The DoR was analyzed for those participants who achieved OR.

The DoR in participants assessed by the investigator is reported. The DoR is defined as the duration from the first documentation of OR (confirmed CR or confirmed PR) to the first documented disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 28 days with no evidence of progression in-between. A confirmed PR is defined as two PRs (\>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) or an un-confirmed PR and an un-confirmed CR that were separated by at least 4 weeks with no evidence of progression in-between. The DoR was estimated using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) n=2 Participants Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) n=2 Participants Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) n=15 Participants Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=7 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=3 Participants Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) n=54 Participants Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) n=4 Participants Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) n=3 Participants Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) n=1 Participants Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) n=2 Participants Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) n=1 Participants Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) n=1 Participants Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) n=42 Participants Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) n=3 Participants Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) n=3 Participants Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
DoR Assessed by Investigator in the Dose-expansion Phase	7.92 Months Interval 6.1 to 9.7	23.51 Months Interval 14.6 to 32.4	26.91 Months Interval 12.7 to Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	19.71 Months Interval 1.9 to 44.0	14.75 Months Interval 12.8 to Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	9.95 Months Interval 8.3 to 16.4	16.20 Months Interval 7.2 to Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	NA Months Interval 7.9 to Median and Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	9.23 Months 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	NA Months Median and Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	NA Months Median and Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	5.36 Months 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	NA Months Interval 14.6 to Median and Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	—	24.87 Months Interval 4.8 to 24.9	8.64 Months Interval 4.4 to 16.3	—

SECONDARY outcome

Timeframe: From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Percentage of participants with disease control assessed by BICR in NSCLC and SCCHN cohorts is reported. Disease control is defined as a BOR of confirmed CR, confirmed PR, or SD based on RECIST v1.1. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 28 days with no evidence of progression in-between. A confirmed PR is defined as two PRs (\>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) or an un-confirmed PR and an unconfirmed CR that were separated by at least 28 days with no evidence of progression in-between. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=55 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=275 Participants Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Disease Control Rate (DCR) Assessed by BICR in NSCLC and SCCHN Cohort in the Dose-expansion Phase	—	—	—	25.5 Percentage of participants Interval 14.7 to 39.0	44.4 Percentage of participants Interval 38.4 to 50.5	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Population: As-treated population included all participants who received any dose of study drug.

Percentage of participants with disease control assessed by the investigator is reported. Disease control is defined as a BOR of confirmed CR, confirmed PR, or SD based on RECIST v1.1. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 28 days with no evidence of progression in-between. A confirmed PR is defined as two PRs (\>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) or an un-confirmed PR and an unconfirmed CR that were separated by at least 28 days with no evidence of progression in-between. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) n=20 Participants Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) n=21 Participants Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) n=62 Participants Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=62 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=22 Participants Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) n=302 Participants Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) n=40 Participants Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) n=21 Participants Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) n=24 Participants Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) n=51 Participants Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) n=40 Participants Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) n=31 Participants Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) n=201 Participants Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) n=20 Participants Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) n=47 Participants Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) n=10 Participants Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
DCR Assessed by Investigator in the Dose-expansion Phase	50.0 Percentage of participants Interval 27.2 to 72.8	28.6 Percentage of participants Interval 11.3 to 52.2	67.7 Percentage of participants Interval 54.7 to 79.1	33.9 Percentage of participants Interval 22.3 to 47.0	45.5 Percentage of participants Interval 25.7 to 70.2	51.7 Percentage of participants Interval 45.9 to 57.4	65.0 Percentage of participants Interval 48.3 to 79.4	57.1 Percentage of participants Interval 34.0 to 78.2	37.5 Percentage of participants Interval 18.8 to 59.4	37.3 Percentage of participants Interval 24.1 to 51.9	22.5 Percentage of participants Interval 10.8 to 38.5	22.6 Percentage of participants Interval 9.6 to 41.1	43.3 Percentage of participants Interval 36.3 to 50.4	0 Percentage of participants 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	44.7 Percentage of participants Interval 30.2 to 59.9	50.0 Percentage of participants Interval 18.7 to 81.3	—

SECONDARY outcome

Timeframe: From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Population: Participants in As-treated population with NSCLC were analyzed. As-treated population included all participants who received any dose of study drug.

The PFS assessed by BICR in NSCLC cohort is reported. The PFS is defined as the time from the start of study treatment until the first documentation of disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. The PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The PFS was estimated using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=304 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Progression-free Survival (PFS) Assessed by BICR in NSCLC Cohort in the Dose-expansion Phase	—	—	—	2.1 Percentage of participants Interval 1.5 to 2.6	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Population: Participants in FAS population with SCCHN were analyzed. FAS population included all participants who received any dose of study drug, had measurable disease at baseline (Day 1) per BICR and were followed for at least 24 weeks by 16Oct2017.

The PFS assessed by BICR in SCCHN cohort is reported. The PFS is defined as the time from the start of study treatment until the first documentation of disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. The PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The PFS was estimated using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=62 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
PFS Assessed by BICR in SCCHN Cohort in the Dose-expansion Phase	—	—	—	1.4 Percentage of participants Interval 1.3 to 1.5	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

The PFS assessed by the investigator is reported. The PFS is defined as the time from the start of study treatment until the first documentation of disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. The PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The PFS was estimated using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) n=20 Participants Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) n=21 Participants Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) n=62 Participants Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=62 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=22 Participants Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) n=302 Participants Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) n=40 Participants Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) n=21 Participants Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) n=24 Participants Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) n=51 Participants Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) n=40 Participants Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) n=31 Participants Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) n=201 Participants Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) n=20 Participants Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) n=47 Participants Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) n=10 Participants Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
PFS Assessed by Investigator in the Dose-expansion Phase	2.6 Months Interval 1.4 to 3.0	1.5 Months Interval 0.9 to 1.8	5.4 Months Interval 2.9 to 11.1	1.4 Months Interval 1.4 to 1.6	1.5 Months Interval 1.2 to 5.6	2.6 Months Interval 1.9 to 3.2	2.7 Months Interval 1.4 to 5.3	2.8 Months Interval 1.2 to 9.1	1.4 Months Interval 1.3 to 4.6	1.4 Months Interval 1.2 to 2.4	1.3 Months Interval 1.2 to 1.6	1.5 Months Interval 1.3 to 1.7	1.8 Months Interval 1.4 to 2.6	1.4 Months Interval 1.2 to 2.3	1.8 Months Interval 1.4 to 2.7	2.2 Months Interval 0.7 to 5.7	—

SECONDARY outcome

Timeframe: From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Population: As-treated population included all participants who received any dose of study drug. The "Number of Participants Analyzed" denotes the number of participants evaluated for this outcome measure.

OS is defined as the time from the start of study treatment until death due to any cause. The OS was estimated using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) n=20 Participants Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) n=21 Participants Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) n=62 Participants Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=62 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=22 Participants Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) n=304 Participants Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) n=40 Participants Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) n=21 Participants Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) n=24 Participants Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) n=51 Participants Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) n=40 Participants Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) n=31 Participants Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) n=201 Participants Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) n=20 Participants Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) n=47 Participants Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) n=10 Participants Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
OS in the Dose-Expansion Phase	15.8 Months Interval 8.1 to 23.3	4.8 Months Interval 1.3 to 10.4	24.1 Months Interval 12.4 to 37.1	8.4 Months Interval 5.7 to 12.3	11.6 Months Interval 3.0 to 22.8	12.4 Months Interval 9.3 to 15.2	13.2 Months Interval 6.3 to 23.0	NA Months Interval 15.1 to Median and Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	8.4 Months Interval 4.5 to 14.3	4.9 Months Interval 2.6 to 9.1	5.5 Months Interval 3.5 to 16.8	5.7 Months Interval 4.8 to 8.0	10.5 Months Interval 6.9 to 15.7	10.0 Months Interval 6.2 to 13.0	11.1 Months Interval 8.2 to 16.6	16.1 Months Interval 0.9 to Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	—

SECONDARY outcome

Timeframe: From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Population: The UC cohort participants with PD-L1 status as low/negative (\<25% tumor cell membrane and \<25% immune cell staining), total (PD-L1 high, PD-L1 low/negative, and PD-L1 unknown), and high (\>= 25% tumor cell membrane or \>=25% immune cell staining) included in the FAS population were analyzed. FAS population included all participnats who received any dose of study drug, had measurable disease at baseline (Day 1) per BICR and were followed for at least 24 weeks by 16Oct2017.

The ORR assessed by BICR in UC cohort is reported. The ORR is defined as confirmed CR or confirmed PR based on RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. A confirmed CR is defined as two CRs that were separated by at least 28 days with no evidence of progression in-between. The PR is defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an un-confirmed CR that were separated by at least 4 weeks with no evidence of progression in-between.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=85 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=199 Participants Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) n=101 Participants Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
ORR Assessed by BICR in UC Cohort (PD-L1 Low/Negative, Total, and PD-L1 High) in the Dose-expansion Phase	—	—	—	5.9 Percentage of participants Interval 1.9 to 13.2	17.6 Percentage of participants Interval 12.6 to 23.6	27.7 Percentage of participants Interval 19.3 to 37.5	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Population: The UC cohort participants with PD-L1 status as low/negative (\<25% tumor cell membrane and \<25% immune cell staining), total (PD-L1 high, PD-L1 low/negative, and PD-L1 unknown), and high (\>= 25% tumor cell membrane or \>=25% immune cell staining) included in the As-treated population were analyzed. As-treated population included all participants who received any dose of study drug.

The ORR assessed by the investigator in UC cohort is reported. The ORR is defined as confirmed CR or confirmed PR based on RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. A confirmed CR is defined as two CRs that were separated by at least 28 days with no evidence of progression in-between. The PR is defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an un-confirmed CR that were separated by at least 4 weeks with no evidence of progression in-between.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=86 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=201 Participants Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) n=102 Participants Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
ORR Assessed by Investigator in UC Cohort (PD-L1 Low/Negative, Total, and PD-L1 High) in the Dose-expansion Phase	—	—	—	7.0 Percentage of participants Interval 2.6 to 14.6	20.9 Percentage of participants Interval 15.5 to 27.2	33.3 Percentage of participants Interval 24.3 to 43.4	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Population: The UC cohort participants with PD-L1 status low/negative (\<25% tumor cell membrane and \<25% immune cell staining), total (PD-L1 high, PD-L1 low/negative, and PD-L1 unknown), and high (\>= 25% tumor cell membrane or \>=25% immune cell staining) included in FAS population (all participants who received any dose of study drug, had measurable disease at baseline (Day 1) per BICR and were followed for at least 24 wks by 16Oct2017) were analyzed. DoR was analyzed for those participants who achieved OR.

The DoR assessed by BICR in UC cohort is reported. The DoR is defined as the duration from the first documentation of OR (confirmed CR or confirmed PR) to the first documented disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 28 days with no evidence of progression in-between. A confirmed PR is defined as two PRs (\>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) or an un-confirmed PR and an un-confirmed CR that were separated by at least 4 weeks with no evidence of progression in-between. The DoR was estimated using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=5 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=35 Participants Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) n=28 Participants Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
DoR Assessed by BICR in UC Cohort (PD-L1 Low/Negative, Total, and PD-L1 High) in the Dose-expansion Phase	—	—	—	12.25 Months Interval 8.6 to Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	NA Months Interval 16.0 to Median and Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	NA Months Interval 16.0 to Median and Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Population: The UC cohort participants with PD-L1 status as low/negative (\<25% tumor cell membrane and \<25% immune cell staining), total (PD-L1 high, PD-L1 low/negative, and PD-L1 unknown), and high (\>= 25% tumor cell membrane or \>=25% immune cell staining) included in the As-treated population were analyzed. As-treated population included all participants who received any dose of study drug. The DoR was analyzed for those participants who achieved OR.

The DoR assessed by investigator in UC cohort is reported. The DoR is defined as the duration from the first documentation of OR (confirmed CR or confirmed PR) to the first documented disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 28 days with no evidence of progression in-between. A confirmed PR is defined as two PRs (\>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) or an un-confirmed PR and an un-confirmed CR that were separated by at least 4 weeks with no evidence of progression in-between. The DoR was estimated using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=6 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=42 Participants Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) n=34 Participants Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
DoR Assessed by Investigator in UC Cohort (PD-L1 Low/Negative, Total, and PD-L1 High) in the Dose-expansion Phase	—	—	—	14.82 Months Interval 6.9 to Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	19.71 Months Interval 14.6 to Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	NA Months Interval 12.3 to Median and Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Population: The UC cohort participants with PD-L1 status as low/negative (\<25% tumor cell membrane and \<25% immune cell staining), total (PD-L1 high, PD-L1 low/negative, and PD-L1 unknown), and high (\>= 25% tumor cell membrane or \>=25% immune cell staining) included in the FAS population were analyzed. FAS population included all participants who received any dose of study drug, had measurable disease at baseline (Day 1) per BICR and were followed for at least 24 weeks by 16Oct2017.

Percentage of participants with disease control assessed by BICR in UC cohort is reported. The DCR is defined as a BOR of confirmed CR, confirmed PR, or SD based on RECIST v1.1. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 28 days with no evidence of progression in-between. A confirmed PR is defined as two PRs (\>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) or an un-confirmed PR and an unconfirmed CR that were separated by at least 28 days with no evidence of progression in-between. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=85 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=199 Participants Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) n=101 Participants Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
DCR Assessed by BICR in UC Cohort (PD-L1 Low/Negative, Total, and PD-L1 High) in the Dose-expansion Phase	—	—	—	21.2 Percentage of participants Interval 13.1 to 31.4	35.2 Percentage of participants Interval 28.6 to 42.2	43.6 Percentage of participants Interval 33.7 to 53.8	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Population: The UC cohort participants with PD-L1 status as low/negative (\<25% tumor cell membrane and \<25% immune cell staining), total (PD-L1 high, PD-L1 low/negative, and PD-L1 unknown), and high (\>= 25% tumor cell membrane or \>=25% immune cell staining) included in the As-treated population were analyzed. As-treated population included all participants who received any dose of study drug.

Percentage of participants with disease control assessed by investigator in UC cohort is reported. Disease control is defined as a best overall response of confirmed CR, confirmed PR, or SD based on RECIST v1.1. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 28 days with no evidence of progression in-between. A confirmed PR is defined as two PRs (\>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) or an un-confirmed PR and an unconfirmed CR that were separated by at least 28 days with no evidence of progression in-between. The SD is defined as neither sufficient shrinkage to qualify for PR not sufficient increase to qualify for disease progression.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=86 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=201 Participants Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) n=102 Participants Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
DCR Assessed by Investigator in UC Cohort (PD-L1 Low/Negative, Total, and PD-L1 High) in the Dose-expansion Phase	—	—	—	30.2 Percentage of participants Interval 20.8 to 41.1	43.3 Percentage of participants Interval 36.3 to 50.4	53.9 Percentage of participants Interval 43.8 to 63.8	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Population: The UC cohort participants with PD-L1 status as low/negative (\<25% tumor cell membrane and \<25% immune cell staining), total (PD-L1 high, PD-L1 low/negative, and PD-L1 unknown), and high (\>= 25% tumor cell membrane or \>=25% immune cell staining) included in the As-treated population were analyzed. As-treated population included all participants who received any dose of study drug. The "Number of participants Analyzed" denotes the number of participants evaluated for this outcome measure.

The PFS assessed by BICR in UC cohort is reported. The PFS is defined as the time from the start of study treatment until the first documentation of disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. The PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The PFS was estimated using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=86 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=201 Participants Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) n=102 Participants Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
PFS Assessed by BICR in UC Cohort (PD-L1 Low/Negative, Total, and PD-L1 High) in the Dose-expansion Phase	—	—	—	1.4 Months Interval 1.3 to 1.5	1.5 Months Interval 1.4 to 1.8	1.9 Months Interval 1.4 to 2.7	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Population: The UC cohort participants with PD-L1 status as low/negative (\<25% tumor cell membrane and \<25% immune cell staining), total (PD-L1 high, PD-L1 low/negative, and PD-L1 unknown), and high (\>= 25% tumor cell membrane or \>=25% immune cell staining) included in the As-treated population were analyzed. As-treated population included all participants who received any dose of study drug. The "Number of participants Analyzed" denotes the number of participants evaluated for this outcome measure.

The PFS assessed by the investigator in UC cohort is reported. The PFS is defined as the time from the start of study treatment until the first documentation of disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. The PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The PFS was estimated using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=86 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=201 Participants Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) n=102 Participants Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
PFS Assessed by Investigator in UC Cohort (PD-L1 Low/Negative, Total, and PD-L1 High) in the Dose-expansion Phase	—	—	—	1.4 Months Interval 1.4 to 1.7	1.8 Months Interval 1.4 to 2.6	2.8 Months Interval 1.8 to 3.7	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Population: The UC cohort participants with PD-L1 status as low/negative (\<25% tumor cell membrane and \<25% immune cell staining), total (PD-L1 high, PD-L1 low/negative, and PD-L1 unknown), and high (\>= 25% tumor cell membrane or \>=25% immune cell staining) included in the As-treated population were analyzed. As-treated population included all participants who received any dose of study drug. The "Number of Participants Analyzed" denotes the number of participants evaluated for this outcome measure.

The OS in UC cohort is reported. The OS is defined as the time from the start of study treatment until death due to any cause. The OS was estimated using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=86 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=201 Participants Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) n=102 Participants Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
OS in UC Cohort (PD-L1 Low/Negative, Total, and PD-L1 High) in the Dose-expansion Phase	—	—	—	4.8 Months Interval 3.3 to 8.1	10.5 Months Interval 6.9 to 15.7	19.8 Months Interval 9.3 to Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Population: The UC cohort participants with PD-L1 status as high (\>= 25% tumor cell membrane or \>=25% immune cell staining) and low/negative (\<25% tumor cell membrane and \<25% immune cell staining) included in the As-treated population were analyzed. As-treated population included all participants who received any dose of study drug. The "Number of participants Analyzed" denotes the number of participants evaluated for this outcome measure.

The PFS by PD-L1 status in UC cohort is reported. The PFS estimates are adjusted for baseline eastern cooperative oncology (ECOG), smoking status, race, gender, age, previous lines of therapy, and liver metastasis. 95% CIs based on log (-log(survival)). The PFS is defined as the time from the start of study treatment until the first documentation of disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. The PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The PFS was estimated using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=61 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=39 Participants Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Adjusted Comparison of PFS by PD-L1 Status in UC Cohort in the Dose-expansion Phase	—	—	—	2.6 Months Interval 1.4 to 3.9	1.5 Months Interval 1.4 to 2.4	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Population: The UC cohort participants with PD-L1 status as high (\>= 25% tumor cell membrane or \>=25% immune cell staining) and low/negative (\<25% tumor cell membrane and \<25% immune cell staining) included in the As-treated population were analyzed. As-treated population included all participants who received any dose of study drug. The "Number of Participants Analyzed" denotes the number of participants evaluated for this outcome measure.

The OS by PD-L1 status in UC cohort is reported. The OS estimates are adjusted for baseline ECOG, smoking status, race, gender, age, previous lines of therapy, and liver metastasis. 95% CIs based on log (-log(survival)). The OS is defined as the time from the start of study treatment until death due to any cause. The OS was estimated using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=61 Participants Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=39 Participants Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first	Escalation Cohort (MEDI4736 1 mg/kg Q2W) Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Adjusted Comparison of OS by PD-L1 Status in UC Cohort in the Dose-expansion Phase	—	—	—	18.4 Months Interval 7.8 to Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	3.4 Months Interval 2.4 to 14.3	—	—	—	—	—	—	—	—	—	—	—	—

Adverse Events

Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 4 deaths

Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)

Serious events: 2 serious events

Other events: 4 other events

Deaths: 2 deaths

Escalation Cohort (MEDI4736 1 mg/kg Q2W)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Escalation Cohort (MEDI4736 3 mg/kg Q2W)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Escalation Cohort (MEDI4736 10 mg/kg Q2W)

Serious events: 3 serious events

Other events: 6 other events

Deaths: 6 deaths

Escalation Cohort (MEDI4736 15 mg/kg Q3W)

Serious events: 3 serious events

Other events: 7 other events

Deaths: 4 deaths

Exploration Durvalumab 20 mg/kg (Q4W)

Serious events: 13 serious events

Other events: 20 other events

Deaths: 17 deaths

Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)

Serious events: 30 serious events

Other events: 61 other events

Deaths: 42 deaths

Expansion Non-SCCHN HPV Positive Cohort (MEDI4736 10 mg/kg Q2W)

Serious events: 16 serious events

Other events: 22 other events

Deaths: 17 deaths

Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)

Serious events: 163 serious events

Other events: 292 other events

Deaths: 208 deaths

Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W)

Serious events: 24 serious events

Other events: 40 other events

Deaths: 30 deaths

Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W)

Serious events: 7 serious events

Other events: 19 other events

Deaths: 8 deaths

Expansion UM Cohort (MEDI4736 10 mg/kg Q2W)

Serious events: 12 serious events

Other events: 22 other events

Deaths: 19 deaths

Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W)

Serious events: 26 serious events

Other events: 50 other events

Deaths: 42 deaths

Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W)

Serious events: 20 serious events

Other events: 39 other events

Deaths: 23 deaths

Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W)

Serious events: 25 serious events

Other events: 31 other events

Deaths: 23 deaths

Expansion UC Cohort (MEDI4736 10 mg/kg Q2W)

Serious events: 117 serious events

Other events: 194 other events

Deaths: 128 deaths

Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W)

Serious events: 9 serious events

Other events: 18 other events

Deaths: 16 deaths

Expansion OC Cohort (MEDI4736 10 mg/kg Q2W)

Serious events: 26 serious events

Other events: 46 other events

Deaths: 36 deaths

Expansion STS Cohort (MEDI4736 10 mg/kg Q2W)

Serious events: 7 serious events

Other events: 20 other events

Deaths: 16 deaths

Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W)

Serious events: 14 serious events

Other events: 17 other events

Deaths: 17 deaths

Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W)

Serious events: 31 serious events

Other events: 57 other events

Deaths: 35 deaths

Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W)

Serious events: 7 serious events

Other events: 10 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=4 participants at risk Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=4 participants at risk Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 1 mg/kg Q2W) n=3 participants at risk Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) n=3 participants at risk Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) n=6 participants at risk Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) n=7 participants at risk Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Exploration Durvalumab 20 mg/kg (Q4W) n=21 participants at risk Participants received IV infusion of MEDI4736 20 mg/kg every 4 weeks (Q4W) in the dose-exploration phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W) n=62 participants at risk Participants with squamous cell carcinoma of the head and neck (SCCHN) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion Non-SCCHN HPV Positive Cohort (MEDI4736 10 mg/kg Q2W) n=22 participants at risk Participants with non-SCCHN human papilloma virus positive (Non-SCCHN HPV+) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W) n=304 participants at risk Participants with non-small-cell lung cancer (NSCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W) n=40 participants at risk Participants with hepatocellular carcinoma (HCC Total) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W) n=21 participants at risk Participants with advance cutaneous melanoma (ACM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UM Cohort (MEDI4736 10 mg/kg Q2W) n=24 participants at risk Participants with uveal melanoma (UM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) n=51 participants at risk Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) n=40 participants at risk Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) n=31 participants at risk Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) n=201 participants at risk Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) n=20 participants at risk Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion OC Cohort (MEDI4736 10 mg/kg Q2W) n=47 participants at risk Participants with ovarian cancer (OC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) n=20 participants at risk Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) n=21 participants at risk Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) n=62 participants at risk Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) n=10 participants at risk Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Vascular disorders Venous thrombosis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Cellulitis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell cancer of the renal pelvis and ureter	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Abdominal pain lower	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Abdominal pain upper	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	13.6% 3/22 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.66% 2/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Dysphagia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.3% 4/304 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Injury, poisoning and procedural complications Fracture	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Injury, poisoning and procedural complications Hip fracture	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Cardiac disorders Myocarditis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Nausea	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.5% 3/201 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Ischaemic neuropathy	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Blood and lymphatic system disorders Anaemia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.5% 3/201 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Blood and lymphatic system disorders Immune thrombocytopenic purpura	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Blood and lymphatic system disorders Leukocytosis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Blood and lymphatic system disorders Lymph node pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Blood and lymphatic system disorders Neutropenia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Cardiac disorders Acute coronary syndrome	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Cardiac disorders Angina pectoris	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Cardiac disorders Atrial fibrillation	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.99% 3/304 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Cardiac disorders Atrial flutter	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.99% 3/304 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Cardiac disorders Atrioventricular block first degree	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Cardiac disorders Cardiac arrest	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.66% 2/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Cardiac disorders Cardiac failure	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Cardiac disorders Cardiac failure congestive	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Cardiac disorders Cardiac tamponade	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Cardiac disorders Cardio-respiratory arrest	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Cardiac disorders Cardiovascular disorder	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Cardiac disorders Ischaemic cardiomyopathy	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Cardiac disorders Myocardial infarction	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Cardiac disorders Palpitations	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Cardiac disorders Pericardial effusion	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.99% 3/304 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Cardiac disorders Sinus tachycardia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Cardiac disorders Supraventricular tachycardia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Cardiac disorders Trifascicular block	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Cardiac disorders Ventricular tachycardia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Endocrine disorders Adrenal insufficiency	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Endocrine disorders Hyperthyroidism	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Endocrine disorders Steroid withdrawal syndrome	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Abdominal pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.1% 2/22 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.99% 3/304 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.9% 2/51 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.7% 3/31 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 5/201 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.4% 3/47 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Ascites	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.9% 3/51 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Colitis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.3% 4/304 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.3% 2/47 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Colitis ischaemic	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Colonic fistula	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Constipation	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Duodenal obstruction	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Duodenal stenosis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Enterovesical fistula	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Faecaloma	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Gastric perforation	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Haematemesis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Ileus	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Intestinal obstruction	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Intestinal perforation	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Intra-abdominal haemorrhage	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Pancreatitis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Proctalgia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Proctitis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Retroperitoneal haemorrhage	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Small intestinal perforation	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Subileus	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Varices oesophageal	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Vomiting	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.66% 2/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 2/31 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 5/201 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders Asthenia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders Chest pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders Chills	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders Complication associated with device	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders Death	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders Fatigue	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.3% 4/304 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders General physical health deterioration	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.99% 3/304 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	7.5% 3/40 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.5% 7/201 • Number of events 11 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders Malaise	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders Multiple organ dysfunction syndrome	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders Non-cardiac chest pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.99% 3/304 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders Oedema	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders Oedema peripheral	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.66% 2/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders Pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders Pyrexia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.99% 3/304 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.3% 2/24 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 2/31 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.5% 3/201 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Hepatobiliary disorders Cholangitis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Hepatobiliary disorders Cholecystitis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Hepatobiliary disorders Cholelithiasis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Hepatobiliary disorders Chronic hepatic failure	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Hepatobiliary disorders Hepatic failure	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.3% 2/24 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Hepatobiliary disorders Hepatic haemorrhage	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Hepatobiliary disorders Hepatic vein thrombosis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Hepatobiliary disorders Hepatobiliary disease	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Hepatobiliary disorders Hepatocellular injury	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Hepatobiliary disorders Liver injury	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Abdominal abscess	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Abdominal infection	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Bacteraemia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Bartholinitis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Bronchitis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Clostridium difficile colitis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Clostridium difficile infection	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Device related infection	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Diverticulitis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.66% 2/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Erysipelas	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Herpes zoster	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Infected fistula	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Kidney infection	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Necrotising fasciitis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Osteomyelitis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Peritonitis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Peritonitis bacterial	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Pneumonia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.9% 21/304 • Number of events 29 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.9% 2/51 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 4/201 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Postoperative wound infection	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Pulmonary tuberculosis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Pyelonephritis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Respiratory tract infection	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.66% 2/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Sepsis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 6/304 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.0% 8/201 • Number of events 10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.3% 2/47 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Septic shock	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Sinusitis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Stoma site infection	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Subcutaneous abscess	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Upper respiratory tract infection	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.66% 2/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Urinary tract candidiasis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Urinary tract infection	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 9/201 • Number of events 13 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.3% 2/47 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Urosepsis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Injury, poisoning and procedural complications Contusion	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Injury, poisoning and procedural complications Fall	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Injury, poisoning and procedural complications Femur fracture	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Investigations Alanine aminotransferase increased	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Investigations Aspartate aminotransferase increased	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Investigations Blood alkaline phosphatase increased	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Investigations Blood bilirubin increased	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Investigations Blood creatinine increased	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Investigations Blood electrolytes decreased	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Investigations Eastern cooperative oncology group performance status worsened	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Investigations Gamma-glutamyltransferase increased	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Investigations International normalised ratio increased	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Investigations Transaminases increased	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Metabolism and nutrition disorders Decreased appetite	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Metabolism and nutrition disorders Dehydration	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.99% 3/304 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 2/31 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.5% 3/201 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Metabolism and nutrition disorders Failure to thrive	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.99% 3/304 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 5/201 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Metabolism and nutrition disorders Hyperlipasaemia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.9% 3/51 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Metabolism and nutrition disorders Hypophagia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.3% 4/304 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 9/201 • Number of events 10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.66% 2/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.5% 3/201 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of the cervix	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.7% 3/31 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	13.6% 3/22 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	22.4% 45/201 • Number of events 50 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer stage iv	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the hypopharynx	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 4/201 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.5% 3/201 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.1% 2/22 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Choroid melanoma	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenocarcinoma	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.1% 5/62 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	7.8% 4/51 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrooesophageal cancer	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma multiforme	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	17.5% 7/40 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraocular melanoma	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.3% 2/24 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.99% 3/304 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.99% 3/304 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.3% 13/304 • Number of events 14 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of renal pelvis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bladder	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic carcinoma of the bladder	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic gastric cancer	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasopharyngeal cancer	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	40.0% 4/10 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm swelling	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.5% 47/304 • Number of events 55 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal cancer metastatic	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.9% 2/51 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.9% 3/51 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oncologic complication	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.9% 7/47 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.8% 8/31 • Number of events 9 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 2/31 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma stage iv	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 2/31 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paraneoplastic syndrome	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	38.1% 8/21 • Number of events 13 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Soft tissue sarcoma	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of head and neck	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.7% 6/62 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.3% 4/304 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of pharynx	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.0% 8/201 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma metastatic	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma recurrent	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Triple negative breast cancer	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour flare	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.5% 3/201 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval cancer metastatic	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Aphasia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Ataxia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Basal ganglia infarction	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Cauda equina syndrome	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Cerebrovascular accident	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Cognitive disorder	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Dizziness	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Dysarthria	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Facial paralysis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.66% 2/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Headache	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Hemianopia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Hemianopia homonymous	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Hemiparesis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Hydrocephalus	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Ischaemic stroke	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Migraine	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Monoparesis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Nerve compression	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Nervous system disorder	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.0% 3/20 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Paraesthesia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Partial seizures	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Peripheral motor neuropathy	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Seizure	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Spinal cord compression	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Spinal cord oedema	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Syncope	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Transient ischaemic attack	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.66% 2/304 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Trigeminal neuralgia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Product Issues Device dislocation	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Product Issues Device malfunction	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Product Issues Device occlusion	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Psychiatric disorders Anxiety	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Psychiatric disorders Confusional state	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Psychiatric disorders Mental status changes	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Psychiatric disorders Suicide attempt	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Renal and urinary disorders Acute kidney injury	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.9% 3/51 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.0% 8/201 • Number of events 9 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Renal and urinary disorders Azotaemia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Renal and urinary disorders Haematuria	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Renal and urinary disorders Hydronephrosis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.5% 3/201 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Renal and urinary disorders Hydroureter	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Renal and urinary disorders Proteinuria	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Renal and urinary disorders Ureteric obstruction	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Renal and urinary disorders Urinary bladder polyp	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Renal and urinary disorders Urinary tract obstruction	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.5% 3/201 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Renal and urinary disorders Urinary tract pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Reproductive system and breast disorders Female genital tract fistula	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Reproductive system and breast disorders Vaginal discharge	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.99% 3/304 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 5/304 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 4/62 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	7.6% 23/304 • Number of events 24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.9% 2/51 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.0% 3/20 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	19.0% 4/21 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.66% 2/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Oesophagobronchial fistula	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Pharyngeal haemorrhage	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.0% 9/304 • Number of events 9 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.99% 3/304 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.3% 4/304 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.3% 4/304 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.66% 2/304 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.99% 3/304 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.3% 2/47 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.66% 2/304 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Pulmonary venous thrombosis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.6% 8/304 • Number of events 9 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.9% 2/51 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Tracheal stenosis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Skin and subcutaneous tissue disorders Erythema	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Vascular disorders Embolism	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.3% 4/304 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Vascular disorders Haematoma	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Vascular disorders Hypertension	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Vascular disorders Hypotension	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.99% 3/304 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Vascular disorders Superior vena cava syndrome	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Vascular disorders Vascular occlusion	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Vascular disorders Vena cava thrombosis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)

Other adverse events

Other adverse events
Measure	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) n=4 participants at risk Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) n=4 participants at risk Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 1 mg/kg Q2W) n=3 participants at risk Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 3 mg/kg Q2W) n=3 participants at risk Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 10 mg/kg Q2W) n=6 participants at risk Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Escalation Cohort (MEDI4736 15 mg/kg Q3W) n=7 participants at risk Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Exploration Durvalumab 20 mg/kg (Q4W) n=21 participants at risk Participants received IV infusion of MEDI4736 20 mg/kg every 4 weeks (Q4W) in the dose-exploration phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W) n=62 participants at risk Participants with squamous cell carcinoma of the head and neck (SCCHN) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion Non-SCCHN HPV Positive Cohort (MEDI4736 10 mg/kg Q2W) n=22 participants at risk Participants with non-SCCHN human papilloma virus positive (Non-SCCHN HPV+) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W) n=304 participants at risk Participants with non-small-cell lung cancer (NSCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W) n=40 participants at risk Participants with hepatocellular carcinoma (HCC Total) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W) n=21 participants at risk Participants with advance cutaneous melanoma (ACM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UM Cohort (MEDI4736 10 mg/kg Q2W) n=24 participants at risk Participants with uveal melanoma (UM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) n=51 participants at risk Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) n=40 participants at risk Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) n=31 participants at risk Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) n=201 participants at risk Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) n=20 participants at risk Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion OC Cohort (MEDI4736 10 mg/kg Q2W) n=47 participants at risk Participants with ovarian cancer (OC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) n=20 participants at risk Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) n=21 participants at risk Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) n=62 participants at risk Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) n=10 participants at risk Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Gastrointestinal disorders Dry mouth	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 4/62 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.6% 17/304 • Number of events 19 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 4/40 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.8% 5/51 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	12.9% 4/31 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.5% 11/201 • Number of events 14 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.1% 5/62 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	20.0% 2/10 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Renal and urinary disorders Urinary incontinence	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.99% 3/304 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 5/201 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	11.3% 7/62 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.3% 16/304 • Number of events 19 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	7.5% 3/40 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 10/201 • Number of events 15 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Constipation	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	50.0% 3/6 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.1% 10/62 • Number of events 11 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	27.3% 6/22 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.8% 48/304 • Number of events 55 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	27.5% 11/40 • Number of events 12 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	19.0% 4/21 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 4/24 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	31.4% 16/51 • Number of events 20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	12.5% 5/40 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	29.0% 9/31 • Number of events 10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	27.4% 55/201 • Number of events 63 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	29.8% 14/47 • Number of events 16 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.0% 3/20 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	19.0% 4/21 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	21.0% 13/62 • Number of events 18 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Diarrhoea	50.0% 2/4 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	50.0% 2/4 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	17.7% 11/62 • Number of events 18 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	27.3% 6/22 • Number of events 9 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	17.4% 53/304 • Number of events 96 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 10/40 • Number of events 12 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	23.8% 5/21 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	20.8% 5/24 • Number of events 10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 17/51 • Number of events 19 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	12.5% 5/40 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	12.9% 4/31 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	17.9% 36/201 • Number of events 52 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	23.4% 11/47 • Number of events 17 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	29.0% 18/62 • Number of events 37 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Blood and lymphatic system disorders Anaemia	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.1% 10/62 • Number of events 11 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	22.7% 5/22 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.5% 47/304 • Number of events 74 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	12.5% 5/40 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 3/21 • Number of events 12 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	13.7% 7/51 • Number of events 20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	12.9% 4/31 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	21.4% 43/201 • Number of events 72 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	21.3% 10/47 • Number of events 12 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	40.0% 8/20 • Number of events 14 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	23.8% 5/21 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	17.7% 11/62 • Number of events 22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Blood and lymphatic system disorders Leukopenia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.99% 3/304 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Blood and lymphatic system disorders Neutropenia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.66% 2/304 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.5% 3/201 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Blood and lymphatic system disorders Splenomegaly	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.6% 8/304 • Number of events 12 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 5/201 • Number of events 9 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.4% 3/47 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Cardiac disorders Atrial fibrillation	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 5/304 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Cardiac disorders Extrasystoles	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Cardiac disorders Palpitations	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 6/304 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 4/201 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Ear and labyrinth disorders Ear pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.66% 2/304 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Ear and labyrinth disorders Eustachian tube dysfunction	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Ear and labyrinth disorders Otorrhoea	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Endocrine disorders Hyperthyroidism	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.1% 2/22 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.9% 12/304 • Number of events 19 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.0% 8/201 • Number of events 10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Endocrine disorders Hypothyroidism	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 3/21 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.1% 5/62 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	13.6% 3/22 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 29/304 • Number of events 34 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 4/40 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 3/21 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.9% 2/51 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 4/40 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.1% 5/31 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.5% 17/201 • Number of events 21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.5% 4/47 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.7% 6/62 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Eye disorders Cataract	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Eye disorders Conjunctival hyperaemia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Eye disorders Diplopia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.66% 2/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Eye disorders Eye pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Eye disorders Vision blurred	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.1% 2/22 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.3% 7/304 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.9% 2/51 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.3% 2/47 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Eye disorders Vitreous floaters	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Abdominal discomfort	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.4% 3/47 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Abdominal distension	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.0% 9/304 • Number of events 10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	12.5% 5/40 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.9% 3/51 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.0% 6/201 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.3% 2/47 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Abdominal pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	28.6% 2/7 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 3/21 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.1% 5/62 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	18.2% 4/22 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	7.6% 23/304 • Number of events 28 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	27.5% 11/40 • Number of events 12 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 4/24 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.5% 13/51 • Number of events 27 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	29.0% 9/31 • Number of events 12 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 20/201 • Number of events 25 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	31.9% 15/47 • Number of events 23 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.0% 3/20 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 3/21 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	19.4% 12/62 • Number of events 24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	30.0% 3/10 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Abdominal pain lower	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	7.5% 3/40 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.5% 3/201 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Abdominal pain upper	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	13.6% 3/22 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.3% 7/304 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	20.0% 8/40 • Number of events 11 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 4/24 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	7.8% 4/51 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 4/40 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 5/201 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.0% 3/20 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Ascites	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.66% 2/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 4/40 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.8% 5/51 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 2/31 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.9% 7/47 • Number of events 11 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Dyspepsia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.3% 10/304 • Number of events 11 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 4/40 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.3% 2/24 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.9% 3/51 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 2/31 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.0% 12/201 • Number of events 12 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.6% 5/47 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Dysphagia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.1% 5/62 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.9% 15/304 • Number of events 18 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	19.6% 10/51 • Number of events 12 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.5% 3/201 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Eructation	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.9% 3/51 • Number of events 9 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Flatulence	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.99% 3/304 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.9% 3/51 • Number of events 9 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	12.9% 4/31 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.3% 2/47 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.6% 11/304 • Number of events 13 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	13.7% 7/51 • Number of events 18 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.1% 5/31 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 4/201 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.4% 3/47 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 3/21 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Loose tooth	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Nausea	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	66.7% 2/3 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	42.9% 3/7 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	19.4% 12/62 • Number of events 15 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	31.8% 7/22 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	22.0% 67/304 • Number of events 82 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	35.0% 14/40 • Number of events 16 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	23.8% 5/21 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	41.7% 10/24 • Number of events 14 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.5% 13/51 • Number of events 26 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	22.5% 9/40 • Number of events 9 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	32.3% 10/31 • Number of events 15 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	23.4% 47/201 • Number of events 70 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 5/20 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	31.9% 15/47 • Number of events 25 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	28.6% 6/21 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	29.0% 18/62 • Number of events 30 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	30.0% 3/10 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Oral pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Stomatitis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.3% 4/304 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.9% 2/51 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.5% 7/201 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Toothache	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.6% 8/304 • Number of events 12 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Gastrointestinal disorders Vomiting	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	28.6% 2/7 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.1% 10/62 • Number of events 13 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	27.3% 6/22 • Number of events 10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	13.5% 41/304 • Number of events 53 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 10/40 • Number of events 16 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	23.8% 5/21 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 4/24 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	19.6% 10/51 • Number of events 35 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	17.5% 7/40 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.8% 8/31 • Number of events 16 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	13.4% 27/201 • Number of events 39 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.0% 3/20 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	21.3% 10/47 • Number of events 15 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	19.0% 4/21 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	12.9% 8/62 • Number of events 15 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	30.0% 3/10 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders Asthenia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	28.6% 2/7 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.1% 2/22 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.6% 14/304 • Number of events 16 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.0% 6/40 • Number of events 12 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	20.8% 5/24 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.9% 3/51 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	12.5% 5/40 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	12.9% 26/201 • Number of events 44 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.5% 4/47 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.1% 10/62 • Number of events 12 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders Chest discomfort	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.5% 3/201 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders Chills	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.1% 2/22 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.3% 13/304 • Number of events 13 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	7.5% 3/40 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	19.0% 4/21 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	7.8% 4/51 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	19.4% 6/31 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.0% 8/201 • Number of events 10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.5% 4/47 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders Face oedema	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders Fatigue	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	50.0% 2/4 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	50.0% 3/6 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	42.9% 3/7 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	38.1% 8/21 • Number of events 13 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.9% 21/62 • Number of events 29 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	50.0% 11/22 • Number of events 13 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	37.5% 114/304 • Number of events 165 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	50.0% 20/40 • Number of events 23 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	47.6% 10/21 • Number of events 10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	37.5% 9/24 • Number of events 12 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	54.9% 28/51 • Number of events 73 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	17.5% 7/40 • Number of events 11 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	61.3% 19/31 • Number of events 24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	36.3% 73/201 • Number of events 91 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	40.0% 8/20 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	40.4% 19/47 • Number of events 23 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	45.0% 9/20 • Number of events 11 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	28.6% 6/21 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	24.2% 15/62 • Number of events 19 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	40.0% 4/10 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders Gait disturbance	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders General physical health deterioration	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.5% 3/201 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders Hernia pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders Influenza like illness	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.3% 7/304 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.9% 7/47 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders Mucosal inflammation	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.3% 4/304 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.9% 2/51 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.0% 6/201 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders Non-cardiac chest pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.6% 17/304 • Number of events 18 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders Oedema peripheral	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	19.0% 4/21 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.1% 5/62 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.2% 31/304 • Number of events 42 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	27.5% 11/40 • Number of events 17 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 3/21 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.3% 2/24 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.8% 5/51 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.0% 6/40 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.7% 3/31 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	13.9% 28/201 • Number of events 33 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	19.1% 9/47 • Number of events 12 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.0% 3/20 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	11.3% 7/62 • Number of events 11 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	20.0% 2/10 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders Pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.0% 9/304 • Number of events 11 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 4/201 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.4% 3/47 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders Peripheral swelling	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 5/304 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders Pyrexia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	75.0% 3/4 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	28.6% 2/7 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.5% 9/62 • Number of events 17 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	18.2% 4/22 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.9% 33/304 • Number of events 45 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.0% 6/40 • Number of events 18 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	19.0% 4/21 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.3% 2/24 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	13.7% 7/51 • Number of events 14 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.0% 6/40 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	12.9% 4/31 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	13.9% 28/201 • Number of events 34 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.0% 3/20 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	17.0% 8/47 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 5/20 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	17.7% 11/62 • Number of events 22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders Swelling face	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
General disorders Thirst	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 2/31 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Hepatobiliary disorders Hepatic pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Hepatobiliary disorders Hepatomegaly	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	7.5% 3/40 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Hepatobiliary disorders Jaundice	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.66% 2/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Hepatobiliary disorders Ocular icterus	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Immune system disorders Food allergy	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Bronchitis	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.1% 2/22 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.6% 11/304 • Number of events 12 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.5% 3/201 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Candida infection	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.66% 2/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 4/201 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Escherichia urinary tract infection	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Eye infection	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.66% 2/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Gingivitis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.99% 3/304 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Herpes zoster	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 6/304 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Influenza	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 5/304 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Nasopharyngitis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.6% 8/304 • Number of events 9 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 9/201 • Number of events 12 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 4/62 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Onychomycosis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	20.0% 2/10 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Oral candidiasis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.1% 2/22 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.3% 13/304 • Number of events 15 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 4/201 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Otitis externa	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Otitis media	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Pneumonia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.2% 25/304 • Number of events 34 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 5/201 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Pyuria	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Rhinitis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.1% 2/22 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 6/304 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Sinusitis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.9% 12/304 • Number of events 14 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 4/201 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Skin infection	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Upper respiratory tract infection	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	7.6% 23/304 • Number of events 29 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 4/24 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.5% 3/201 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.5% 4/47 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	12.9% 8/62 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Urinary tract infection	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	66.7% 2/3 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	22.7% 5/22 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.9% 15/304 • Number of events 17 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 4/40 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.3% 2/24 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.9% 3/51 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.7% 3/31 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	17.4% 35/201 • Number of events 55 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	17.0% 8/47 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	20.0% 4/20 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.1% 10/62 • Number of events 14 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.66% 2/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Injury, poisoning and procedural complications Fall	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.3% 7/304 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.3% 2/24 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.0% 6/201 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.4% 3/47 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Injury, poisoning and procedural complications Infusion related reaction	25.0% 1/4 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.99% 3/304 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.3% 2/47 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Injury, poisoning and procedural complications Scar	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Injury, poisoning and procedural complications Soft tissue injury	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Injury, poisoning and procedural complications Spinal column injury	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Investigations Activated partial thromboplastin time prolonged	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.99% 3/304 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 2/31 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 4/201 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Investigations Alanine aminotransferase increased	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.1% 2/22 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.2% 19/304 • Number of events 25 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	22.5% 9/40 • Number of events 20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 4/40 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	19.4% 6/31 • Number of events 14 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.5% 17/201 • Number of events 21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.9% 7/47 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.1% 5/62 • Number of events 9 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Investigations Aspartate aminotransferase increased	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 4/62 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	13.6% 3/22 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.6% 20/304 • Number of events 26 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	50.0% 20/40 • Number of events 30 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.3% 2/24 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.9% 3/51 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	17.5% 7/40 • Number of events 12 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.1% 5/31 • Number of events 13 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.5% 17/201 • Number of events 21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.6% 5/47 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.1% 5/62 • Number of events 11 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	20.0% 2/10 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Investigations Blood alkaline phosphatase increased	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 4/62 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.3% 16/304 • Number of events 21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	22.5% 9/40 • Number of events 14 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 4/24 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.9% 3/51 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 4/40 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.1% 5/31 • Number of events 12 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.5% 11/201 • Number of events 12 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.5% 4/47 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.0% 3/20 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 4/62 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Investigations Blood bilirubin increased	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.1% 2/22 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.6% 8/304 • Number of events 12 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.0% 6/40 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	12.5% 3/24 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 2/31 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 5/201 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.3% 2/47 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Investigations Blood cholesterol increased	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.99% 3/304 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Investigations Blood creatinine increased	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.9% 12/304 • Number of events 21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.9% 2/51 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.4% 21/201 • Number of events 27 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Investigations Blood electrolytes decreased	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Investigations Blood fibrinogen increased	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.3% 4/304 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.7% 3/31 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Investigations Blood magnesium decreased	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Investigations Blood thyroid stimulating hormone increased	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.6% 8/304 • Number of events 10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Investigations Cortisol decreased	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Investigations Gamma-glutamyltransferase increased	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.1% 5/62 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.9% 12/304 • Number of events 13 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	20.0% 8/40 • Number of events 10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	12.5% 3/24 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.9% 3/51 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	17.5% 7/40 • Number of events 11 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	22.6% 7/31 • Number of events 15 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.5% 11/201 • Number of events 14 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.5% 4/47 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 3/21 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 4/62 • Number of events 10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Investigations International normalised ratio increased	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.99% 3/304 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 4/201 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.3% 2/47 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Investigations Transaminases increased	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 2/31 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Investigations Vitamin d decreased	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Investigations Weight decreased	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.7% 6/62 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.1% 2/22 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	7.9% 24/304 • Number of events 30 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.9% 2/51 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	19.4% 6/31 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.0% 16/201 • Number of events 19 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	19.1% 9/47 • Number of events 13 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 4/62 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	20.0% 2/10 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Investigations Weight increased	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.0% 9/304 • Number of events 14 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Investigations White blood cell count increased	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Metabolism and nutrition disorders Decreased appetite	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 2/6 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 7/21 • Number of events 9 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	11.3% 7/62 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	18.2% 4/22 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	26.3% 80/304 • Number of events 112 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	37.5% 15/40 • Number of events 17 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	28.6% 6/21 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	20.8% 5/24 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	43.1% 22/51 • Number of events 38 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.0% 6/40 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	35.5% 11/31 • Number of events 12 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.4% 51/201 • Number of events 60 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	20.0% 4/20 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	29.8% 14/47 • Number of events 17 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	19.0% 4/21 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.1% 10/62 • Number of events 14 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Metabolism and nutrition disorders Dehydration	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 3/21 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	11.3% 7/62 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.1% 2/22 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.9% 18/304 • Number of events 24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	19.0% 4/21 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.7% 8/51 • Number of events 11 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.1% 5/31 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 9/201 • Number of events 12 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.6% 5/47 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 4/62 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	20.0% 2/10 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Metabolism and nutrition disorders Fluid intake reduced	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.9% 12/304 • Number of events 15 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 4/40 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.9% 2/51 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 2/31 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.0% 6/201 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.3% 7/304 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.3% 2/24 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	7.5% 15/201 • Number of events 20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 6/304 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	7.5% 3/40 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 9/201 • Number of events 9 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.6% 20/304 • Number of events 22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 4/40 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	7.5% 3/40 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 2/31 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 9/201 • Number of events 10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.3% 2/47 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 3/21 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 5/304 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	7.8% 4/51 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 9 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.66% 2/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.5% 4/47 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	7.2% 22/304 • Number of events 29 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.5% 11/201 • Number of events 13 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.0% 3/20 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.5% 4/47 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.7% 6/62 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.3% 13/304 • Number of events 17 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	7.5% 3/40 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.9% 2/51 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 2/31 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.0% 12/201 • Number of events 15 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.9% 7/47 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	19.0% 4/21 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 4/62 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.1% 5/62 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.2% 31/304 • Number of events 49 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	12.5% 5/40 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.8% 5/51 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	7.5% 3/40 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.7% 3/31 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 20/201 • Number of events 25 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	28.6% 6/21 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 4/62 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Metabolism and nutrition disorders Iron deficiency	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Metabolism and nutrition disorders Polydipsia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Musculoskeletal and connective tissue disorders Arthralgia	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	50.0% 2/4 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 4/62 • Number of events 9 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	13.6% 3/22 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.5% 44/304 • Number of events 62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.0% 6/40 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	42.9% 9/21 • Number of events 14 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 4/24 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 4/40 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.7% 3/31 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	12.4% 25/201 • Number of events 40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	23.4% 11/47 • Number of events 15 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 5/20 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 3/21 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.5% 9/62 • Number of events 14 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	20.0% 2/10 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	11.3% 7/62 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	18.2% 4/22 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.1% 49/304 • Number of events 56 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.0% 6/40 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 3/21 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.3% 2/24 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.5% 13/51 • Number of events 16 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.0% 6/40 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.8% 8/31 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.9% 30/201 • Number of events 44 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	17.0% 8/47 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	20.0% 4/20 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	19.0% 4/21 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	22.6% 14/62 • Number of events 20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Musculoskeletal and connective tissue disorders Coccydynia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	13.6% 3/22 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 4/201 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.4% 3/47 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.3% 10/304 • Number of events 10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 4/24 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.7% 3/31 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.5% 7/201 • Number of events 10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.3% 2/47 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.6% 8/304 • Number of events 11 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.1% 5/62 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.2% 25/304 • Number of events 31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 4/40 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 3/21 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.0% 6/40 • Number of events 9 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 5/201 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	20.0% 4/20 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	28.6% 2/7 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 3/21 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.9% 18/304 • Number of events 23 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.0% 6/40 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.3% 2/24 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.8% 5/51 • Number of events 33 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 2/31 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.0% 16/201 • Number of events 23 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.4% 3/47 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.0% 3/20 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	11.3% 7/62 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.2% 31/304 • Number of events 41 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	7.5% 3/40 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	20.8% 5/24 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.9% 3/51 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 4/40 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.7% 3/31 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	7.0% 14/201 • Number of events 23 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.5% 4/47 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.1% 5/62 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	11.3% 7/62 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.3% 7/304 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.9% 2/51 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.5% 3/201 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.6% 26/304 • Number of events 32 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	7.5% 3/40 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 3/21 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.9% 2/51 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.5% 11/201 • Number of events 15 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	20.0% 4/20 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.99% 3/304 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	7.5% 3/40 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 4/201 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.3% 4/304 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 10/201 • Number of events 12 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Aphasia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.0% 3/20 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Ataxia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.66% 2/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Dizziness	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	66.7% 2/3 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	28.6% 2/7 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.1% 5/62 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	7.6% 23/304 • Number of events 24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.0% 6/40 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 3/21 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.3% 2/24 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	17.6% 9/51 • Number of events 22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 4/40 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.1% 5/31 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.5% 11/201 • Number of events 14 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.6% 5/47 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 3/21 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.1% 5/62 • Number of events 9 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Dizziness postural	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Dysarthria	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Dysgeusia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 5/304 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 2/31 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.5% 3/201 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.3% 2/47 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	30.0% 3/10 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Headache	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	12.9% 8/62 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.1% 2/22 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.9% 33/304 • Number of events 46 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 4/24 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.8% 5/51 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	17.5% 7/40 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	22.6% 7/31 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 10/201 • Number of events 15 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	45.0% 9/20 • Number of events 11 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	12.8% 6/47 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	19.0% 4/21 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.5% 9/62 • Number of events 14 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	40.0% 4/10 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Hemiparesis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Hypoaesthesia	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.99% 3/304 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	20.0% 2/10 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Lethargy	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.99% 3/304 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.9% 2/51 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Nervous system disorder	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Neuropathy peripheral	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.3% 7/304 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	7.8% 4/51 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 2/31 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 9/201 • Number of events 10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Paraesthesia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 6/304 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 4/62 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	20.0% 2/10 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Parosmia	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Peripheral motor neuropathy	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.66% 2/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Somnolence	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	7.5% 3/40 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.9% 2/51 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Syncope	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 4/62 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Taste disorder	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.3% 4/304 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.9% 2/51 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Nervous system disorders Tremor	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 6/304 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 4/201 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Psychiatric disorders Anxiety	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.3% 16/304 • Number of events 18 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.9% 2/51 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.5% 7/201 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.5% 4/47 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	12.9% 8/62 • Number of events 9 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Psychiatric disorders Confusional state	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 5/304 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	12.9% 4/31 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.0% 8/201 • Number of events 10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.0% 3/20 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Psychiatric disorders Depression	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.3% 10/304 • Number of events 10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.9% 3/51 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.0% 8/201 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.3% 2/47 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Psychiatric disorders Insomnia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.1% 2/22 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	7.9% 24/304 • Number of events 26 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	17.5% 7/40 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.3% 2/24 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.5% 13/51 • Number of events 25 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 20/201 • Number of events 22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.5% 4/47 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 3/21 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	11.3% 7/62 • Number of events 10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Renal and urinary disorders Acute kidney injury	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.99% 3/304 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.0% 8/201 • Number of events 14 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.3% 2/47 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.1% 5/62 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Renal and urinary disorders Dysuria	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.66% 2/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.0% 6/201 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Renal and urinary disorders Haematuria	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.0% 18/201 • Number of events 28 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.4% 3/47 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Renal and urinary disorders Nocturia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Renal and urinary disorders Pollakiuria	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.66% 2/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.5% 3/201 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Renal and urinary disorders Polyuria	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Renal and urinary disorders Proteinuria	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.0% 9/304 • Number of events 11 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 4/201 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.4% 3/47 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Renal and urinary disorders Urinary tract pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.1% 2/22 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Reproductive system and breast disorders Pelvic pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 4/201 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.3% 2/47 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	57.1% 4/7 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.5% 9/62 • Number of events 11 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.1% 2/22 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.3% 77/304 • Number of events 102 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	17.5% 7/40 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	19.0% 4/21 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	20.8% 5/24 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	23.5% 12/51 • Number of events 15 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	12.5% 5/40 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.8% 8/31 • Number of events 10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	11.9% 24/201 • Number of events 27 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	28.6% 6/21 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.1% 10/62 • Number of events 13 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	20.0% 2/10 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.1% 2/22 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.3% 13/304 • Number of events 15 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 2/31 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 4/201 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Dyspnoea	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	42.9% 3/7 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	24.2% 15/62 • Number of events 21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	22.7% 5/22 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	24.7% 75/304 • Number of events 100 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	20.0% 8/40 • Number of events 10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 6/24 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 17/51 • Number of events 22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 10/40 • Number of events 14 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	29.0% 9/31 • Number of events 10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	13.4% 27/201 • Number of events 35 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	19.1% 9/47 • Number of events 10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 5/20 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 3/21 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.1% 5/62 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	20.0% 2/10 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.6% 8/304 • Number of events 9 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 4/201 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.4% 3/47 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 4/62 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	7.9% 24/304 • Number of events 29 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.0% 8/201 • Number of events 10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.99% 3/304 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.9% 2/51 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.5% 3/201 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Nasal congestion	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	66.7% 2/3 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.3% 10/304 • Number of events 13 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	12.5% 3/24 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	7.8% 4/51 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 4/201 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.3% 2/47 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 4/62 • Number of events 9 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	11.3% 7/62 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.6% 17/304 • Number of events 20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.9% 2/51 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 9/201 • Number of events 9 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.3% 2/47 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	20.0% 2/10 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.1% 5/62 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.6% 14/304 • Number of events 19 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.9% 2/51 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 2/31 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.5% 4/47 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 6/304 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 5/304 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.6% 20/304 • Number of events 23 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 10/201 • Number of events 13 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.3% 2/47 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	28.6% 2/7 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.3% 4/304 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.7% 3/31 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.5% 3/201 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Sinus congestion	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.99% 3/304 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.6% 8/304 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.9% 15/304 • Number of events 17 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.5% 3/201 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.3% 2/47 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Skin and subcutaneous tissue disorders Acne	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.6% 14/304 • Number of events 15 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.3% 2/24 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.9% 2/51 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 2/31 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.5% 7/201 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.4% 3/47 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 1/10 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Skin and subcutaneous tissue disorders Erythema	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.7% 6/62 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 6/304 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.5% 3/201 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Skin and subcutaneous tissue disorders Exfoliative rash	25.0% 1/4 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 5/304 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.3% 2/24 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.8% 5/51 • Number of events 15 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 2/31 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.5% 3/201 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.6% 8/304 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.5% 7/201 • Number of events 9 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	10.0% 2/20 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Skin and subcutaneous tissue disorders Pemphigoid	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/304 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/201 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.66% 2/304 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 3/21 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.1% 5/62 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.1% 2/22 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	11.5% 35/304 • Number of events 49 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	40.0% 16/40 • Number of events 20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	23.8% 5/21 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 4/24 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	11.8% 6/51 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	12.5% 5/40 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.1% 5/31 • Number of events 8 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	7.5% 15/201 • Number of events 20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.9% 7/47 • Number of events 10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.0% 3/20 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.1% 10/62 • Number of events 12 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	20.0% 2/10 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Skin and subcutaneous tissue disorders Rash	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	50.0% 2/4 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	66.7% 2/3 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.7% 6/62 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.1% 2/22 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	12.2% 37/304 • Number of events 54 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	12.5% 5/40 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	19.0% 4/21 • Number of events 7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	29.2% 7/24 • Number of events 12 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	17.6% 9/51 • Number of events 13 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	12.9% 4/31 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	11.4% 23/201 • Number of events 28 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.3% 2/47 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	20.0% 2/10 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	6.5% 4/62 • Number of events 6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.3% 7/304 • Number of events 13 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 1/31 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 5/201 • Number of events 13 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	8.1% 5/62 • Number of events 5 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Skin and subcutaneous tissue disorders Vitiligo	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.2% 1/24 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.00% 2/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Vascular disorders Deep vein thrombosis	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.5% 1/22 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.99% 3/304 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/51 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.5% 3/201 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Vascular disorders Hot flush	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	14.3% 1/7 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.3% 4/304 • Number of events 4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 2/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.5% 3/201 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.0% 3/20 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Vascular disorders Hypertension	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	25.0% 1/4 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	33.3% 1/3 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.6% 11/304 • Number of events 16 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.9% 2/51 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.5% 7/201 • Number of events 13 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	15.0% 3/20 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/47 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 1/20 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.2% 2/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Vascular disorders Hypotension	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/6 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	3.9% 12/304 • Number of events 12 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.5% 1/40 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	5.0% 10/201 • Number of events 12 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	9.5% 2/21 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 3/62 • Number of events 3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Vascular disorders Lymphoedema	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/4 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/3 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/7 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/62 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/22 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.33% 1/304 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/24 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.0% 1/51 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/40 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/31 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.50% 1/201 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	2.1% 1/47 • Number of events 1 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/20 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/21 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	1.6% 1/62 • Number of events 2 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)	0.00% 0/10 • From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)

Additional Information

Ashok Gupta

MedImmune, LLC

Phone: +13013981287

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
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