Trial Outcomes & Findings for PROCLAIM-CX-072: A Trial to Find Safe and Active Doses of an Investigational Drug CX-072 for Patients With Solid Tumors or Lymphomas (NCT NCT03013491)

Last Updated: 2025-06-17

Results Overview

Adverse events (AEs) that were considered DLTs: * Grade 5 AEs * Grade 4 AEs judged by the Investigator to be treatment-related or judged by the Sponsor as a DLT, regardless of Investigator-attribution (with some exceptions) • Any Grade 4 endocrinopathy. * Grade 3 AEs judged by the Investigator to be treatment-related or by the Sponsor, regardless of Investigator-attribution (with some exceptions) • Any Grade 3 central nervous system event, regardless of duration or reversibility. * Grade 2 pneumonitis necessitating CX-072 discontinuation * Grade 2 ocular toxicity necessitating CX-072 discontinuation

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

196 participants

Primary outcome timeframe

28 days (dose limiting toxicity period)

Results posted on

2025-06-17

Participant Flow

A total of 278 patients were screened for the study, and 196 patients received study treatment.

Participant milestones

Participant milestones
Measure	CX-072 0.03 mg/kg (Part A and Part A2) Monotherapy CX-072 0.03 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 0.1 mg/kg (Part A and Part A2) Monotherapy CX-072 0.1 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 0.3 mg/kg (Part A and Part A2) Monotherapy CX-072 0.3 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 1 mg/kg (Part A and Part A2) Monotherapy CX-072 1 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 3 mg/kg (Part A and Part A2) Monotherapy CX-072 3 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 10 mg/kg (Part A and Part A2) Monotherapy CX-072 10 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 30 mg/kg (Part A and Part A2) Monotherapy CX-072 30 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 0.3 mg/kg + Ipilimumab 3 mg/kg (Part B1) Combination CX-072 0.3 mg/kg + ipilimumab 3 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 1 mg/kg + Ipilimumab 3 mg/kg (Part B1) Combination CX-072 1 mg/kg + ipilimumab 3 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 3 mg/kg + Ipilimumab 3 mg/kg (Part B1) Combination CX-072 3 mg/kg + ipilimumab 3 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 10 mg/kg + Ipilimumab 3 mg/kg (Part B1) Combination CX-072 10 mg/kg + ipilimumab 3 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 10 mg/kg + Ipilimumab 6 mg/kg (Part B1) Combination CX-072 10 mg/kg + ipilimumab 6 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 10 mg/kg + Ipilimumab 10 mg/kg (Part B1) Combination CX-072 10 mg/kg + ipilimumab 10 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 3 mg/kg + Ipilimumab 3 mg/kg (Part B2) Combination CX-072 3 mg/kg + ipilimumab 3 mg/kg (Part B2) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 10 mg/kg + Ipilimumab 3 mg/kg (Part B2) Combination CX-072 3 mg/kg + ipilimumab 3 mg/kg (Part B2) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 1 mg/kg + Vemurafenib 960 mg (Part C) Combination CX-072 1 mg/kg + Vemurafenib 960 mg (Part C) CX-072: Solution for infusion Vemurafenib: Tablet	CX-072 3 mg/kg + Vemurafenib 960 mg (Part C) Combination CX-072 3 mg/kg + Vemurafenib 960 mg (Part C) CX-072: Solution for infusion Vemurafenib: Tablet	CX-072 10 mg/kg + Vemurafenib 960 mg (Part C) Combination CX-072 10 mg/kg + Vemurafenib 960 mg (Part C) CX-072: Solution for infusion Vemurafenib: Tablet	CX-072 10 mg/kg (Part D) Monotherapy CX-072 10 mg/kg expansion (Part D)
Main Study STARTED	2	2	8	9	13	16	3	6	3	3	8	6	1	6	1	3	6	2	98
Main Study COMPLETED	0	0	0	1	0	0	0	1	0	0	0	0	0	0	1	0	1	0	11
Main Study NOT COMPLETED	2	2	8	8	13	16	3	5	3	3	8	6	1	6	0	3	5	2	87
Long-term Extension STARTED	0	0	0	1	0	0	0	1	0	0	0	0	0	0	1	0	1	0	11
Long-term Extension COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	8
Long-term Extension NOT COMPLETED	0	0	0	1	0	0	0	1	0	0	0	0	0	0	0	0	0	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	CX-072 0.03 mg/kg (Part A and Part A2) Monotherapy CX-072 0.03 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 0.1 mg/kg (Part A and Part A2) Monotherapy CX-072 0.1 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 0.3 mg/kg (Part A and Part A2) Monotherapy CX-072 0.3 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 1 mg/kg (Part A and Part A2) Monotherapy CX-072 1 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 3 mg/kg (Part A and Part A2) Monotherapy CX-072 3 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 10 mg/kg (Part A and Part A2) Monotherapy CX-072 10 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 30 mg/kg (Part A and Part A2) Monotherapy CX-072 30 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 0.3 mg/kg + Ipilimumab 3 mg/kg (Part B1) Combination CX-072 0.3 mg/kg + ipilimumab 3 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 1 mg/kg + Ipilimumab 3 mg/kg (Part B1) Combination CX-072 1 mg/kg + ipilimumab 3 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 3 mg/kg + Ipilimumab 3 mg/kg (Part B1) Combination CX-072 3 mg/kg + ipilimumab 3 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 10 mg/kg + Ipilimumab 3 mg/kg (Part B1) Combination CX-072 10 mg/kg + ipilimumab 3 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 10 mg/kg + Ipilimumab 6 mg/kg (Part B1) Combination CX-072 10 mg/kg + ipilimumab 6 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 10 mg/kg + Ipilimumab 10 mg/kg (Part B1) Combination CX-072 10 mg/kg + ipilimumab 10 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 3 mg/kg + Ipilimumab 3 mg/kg (Part B2) Combination CX-072 3 mg/kg + ipilimumab 3 mg/kg (Part B2) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 1 mg/kg + Vemurafenib 960 mg (Part C) Combination CX-072 1 mg/kg + Vemurafenib 960 mg (Part C) CX-072: Solution for infusion Vemurafenib: Tablet	CX-072 3 mg/kg + Vemurafenib 960 mg (Part C) Combination CX-072 3 mg/kg + Vemurafenib 960 mg (Part C) CX-072: Solution for infusion Vemurafenib: Tablet	CX-072 10 mg/kg + Vemurafenib 960 mg (Part C) Combination CX-072 10 mg/kg + Vemurafenib 960 mg (Part C) CX-072: Solution for infusion Vemurafenib: Tablet	CX-072 10 mg/kg (Part D) Monotherapy CX-072 10 mg/kg expansion (Part D)
Main Study Death	2	2	5	3	9	12	3	5	1	2	4	1	1	4	3	5	1	47
Main Study Lost to Follow-up	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	3
Main Study Termination of the study by Sponsor	0	0	2	0	1	2	0	0	1	1	1	2	0	0	0	0	1	13
Main Study Withdrawal by Subject	0	0	0	4	2	1	0	0	0	0	1	2	0	2	0	0	0	18
Main Study Disease progression	0	0	0	1	0	0	0	0	1	0	1	0	0	0	0	0	0	4
Main Study Symptomatic deterioration	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Main Study Protocol version 8.0 approval	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Main Study Partial withdrawal with survival follow-up only	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Main Study Start of new anticancer therapy	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2
Long-term Extension Disease progression	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Long-term Extension Withdrawal by Subject	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Long-term Extension Adverse Event	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Long-term Extension Death	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1

Baseline Characteristics

PROCLAIM-CX-072: A Trial to Find Safe and Active Doses of an Investigational Drug CX-072 for Patients With Solid Tumors or Lymphomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CX-072 0.03 mg/kg (Part A and Part A2) n=2 Participants Monotherapy CX-072 0.03 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 0.1 mg/kg (Part A and Part A2) n=2 Participants Monotherapy CX-072 0.1 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 0.3 mg/kg (Part A and Part A2) n=8 Participants Monotherapy CX-072 0.3 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 1 mg/kg (Part A and Part A2) n=9 Participants Monotherapy CX-072 1 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 3 mg/kg (Part A and Part A2) n=13 Participants Monotherapy CX-072 3 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 10 mg/kg (Part A and Part A2) n=16 Participants Monotherapy CX-072 10 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 30 mg/kg (Part A and Part A2) n=3 Participants Monotherapy CX-072 30 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 0.3 mg/kg + Ipilimumab 3 mg/kg (Part B1) n=6 Participants Combination CX-072 0.3 mg/kg + ipilimumab 3 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 1 mg/kg + Ipilimumab 3 mg/kg (Part B1) n=3 Participants Combination CX-072 1 mg/kg + ipilimumab 3 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 3 mg/kg + Ipilimumab 3 mg/kg (Part B1) n=3 Participants Combination CX-072 3 mg/kg + ipilimumab 3 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 10 mg/kg + Ipilimumab 3 mg/kg (Part B1) n=8 Participants Combination CX-072 10 mg/kg + ipilimumab 3 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 10 mg/kg + Ipilimumab 6 mg/kg (Part B1) n=6 Participants Combination CX-072 10 mg/kg + ipilimumab 6 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 10 mg/kg + Ipilimumab 10 mg/kg (Part B1) n=1 Participants Combination CX-072 10 mg/kg + ipilimumab 10 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 3 mg/kg + Ipilimumab 3 mg/kg (Part B2) n=6 Participants Combination CX-072 3 mg/kg + ipilimumab 3 mg/kg (Part B2) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 10 mg/kg + Ipilimumab 3 mg/kg (Part B2) n=1 Participants Combination CX-072 3 mg/kg + ipilimumab 3 mg/kg (Part B2) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 1 mg/kg + Vemurafenib 960 mg (Part C) n=3 Participants Combination CX-072 1 mg/kg + Vemurafenib 960 mg (Part C) CX-072: Solution for infusion Vemurafenib: Tablet	CX-072 3 mg/kg + Vemurafenib 960 mg (Part C) n=6 Participants Combination CX-072 3 mg/kg + Vemurafenib 960 mg (Part C) CX-072: Solution for infusion Vemurafenib: Tablet	CX-072 10 mg/kg + Vemurafenib 960 mg (Part C) n=2 Participants Combination CX-072 10 mg/kg + Vemurafenib 960 mg (Part C) CX-072: Solution for infusion Vemurafenib: Tablet	CX-072 10 mg/kg (Part D) n=98 Participants Monotherapy CX-072 10 mg/kg expansion (Part D)	Total n=196 Participants Total of all reporting groups
Age, Continuous	69.5 Years STANDARD_DEVIATION 2.12 • n=5 Participants	72.0 Years STANDARD_DEVIATION 2.83 • n=7 Participants	60.8 Years STANDARD_DEVIATION 9.88 • n=5 Participants	59.2 Years STANDARD_DEVIATION 9.43 • n=4 Participants	63.3 Years STANDARD_DEVIATION 15.12 • n=21 Participants	55.3 Years STANDARD_DEVIATION 13.11 • n=8 Participants	58.0 Years STANDARD_DEVIATION 10.44 • n=8 Participants	56.5 Years STANDARD_DEVIATION 16.94 • n=24 Participants	38.0 Years STANDARD_DEVIATION 1.73 • n=42 Participants	53.0 Years STANDARD_DEVIATION 8.72 • n=42 Participants	53.9 Years STANDARD_DEVIATION 9.14 • n=42 Participants	51.8 Years STANDARD_DEVIATION 10.19 • n=42 Participants	67.0 Years STANDARD_DEVIATION NA • n=36 Participants	56.7 Years STANDARD_DEVIATION 8.38 • n=36 Participants	40 Years STANDARD_DEVIATION NA • n=24 Participants	47.3 Years STANDARD_DEVIATION 17.24 • n=135 Participants	46.3 Years STANDARD_DEVIATION 20.88 • n=136 Participants	53.5 Years STANDARD_DEVIATION 9.19 • n=44 Participants	59.9 Years STANDARD_DEVIATION 12.28 • n=667 Participants	58.1 Years STANDARD_DEVIATION 12.87 • n=12 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	8 Participants n=21 Participants	9 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	3 Participants n=42 Participants	6 Participants n=42 Participants	3 Participants n=42 Participants	1 Participants n=36 Participants	4 Participants n=36 Participants	1 Participants n=24 Participants	2 Participants n=135 Participants	4 Participants n=136 Participants	1 Participants n=44 Participants	60 Participants n=667 Participants	116 Participants n=12 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	5 Participants n=21 Participants	7 Participants n=8 Participants	2 Participants n=8 Participants	4 Participants n=24 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants	3 Participants n=42 Participants	0 Participants n=36 Participants	2 Participants n=36 Participants	0 Participants n=24 Participants	1 Participants n=135 Participants	2 Participants n=136 Participants	1 Participants n=44 Participants	38 Participants n=667 Participants	80 Participants n=12 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	7 Participants n=667 Participants	15 Participants n=12 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	10 Participants n=21 Participants	14 Participants n=8 Participants	2 Participants n=8 Participants	6 Participants n=24 Participants	2 Participants n=42 Participants	3 Participants n=42 Participants	6 Participants n=42 Participants	4 Participants n=42 Participants	1 Participants n=36 Participants	6 Participants n=36 Participants	1 Participants n=24 Participants	3 Participants n=135 Participants	6 Participants n=136 Participants	2 Participants n=44 Participants	70 Participants n=667 Participants	153 Participants n=12 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	21 Participants n=667 Participants	28 Participants n=12 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=12 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	2 Participants n=667 Participants	5 Participants n=12 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	1 Participants n=667 Participants	1 Participants n=12 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	1 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	1 Participants n=44 Participants	8 Participants n=667 Participants	11 Participants n=12 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	10 Participants n=21 Participants	15 Participants n=8 Participants	2 Participants n=8 Participants	6 Participants n=24 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	5 Participants n=42 Participants	5 Participants n=42 Participants	1 Participants n=36 Participants	5 Participants n=36 Participants	1 Participants n=24 Participants	3 Participants n=135 Participants	6 Participants n=136 Participants	1 Participants n=44 Participants	67 Participants n=667 Participants	148 Participants n=12 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=12 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	3 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	20 Participants n=667 Participants	31 Participants n=12 Participants

PRIMARY outcome

Timeframe: 28 days (dose limiting toxicity period)

Population: The safety analysis population includes all enrolled subjects who receive at least one dose of study drug.

Outcome measures

Outcome measures
Measure	CX-072 0.03 mg/kg (Part A and Part A2) n=2 Participants Monotherapy CX-072 0.03 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 0.1 mg/kg (Part A and Part A2) n=2 Participants Monotherapy CX-072 0.1 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 0.3 mg/kg (Part A and Part A2) n=8 Participants Monotherapy CX-072 0.3 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 1 mg/kg (Part A and A2) n=9 Participants Monotherapy CX-072 1 mg/kg (Part A and A2) CX-072: Solution for infusion	CX-072 3 mg/kg (Part A and Part A2) n=13 Participants Monotherapy CX-072 3 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 10 mg/kg (Part A and Part A2) n=16 Participants Monotherapy CX-072 10 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 30 mg/kg (Part A and Part A2) n=3 Participants Monotherapy CX-072 30 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 0.3 mg/kg + Ipilimumab 3 mg/kg (Part B1) n=6 Participants Combination CX-072 0.3 mg/kg + ipilimumab 3 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 1 mg/kg + Ipilimumab 3 mg/kg (Part B1) n=3 Participants Combination CX-072 1 mg/kg + ipilimumab 3 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 3 mg/kg + Ipilimumab 3 mg/kg (Part B1) n=3 Participants Combination CX-072 3 mg/kg + ipilimumab 3 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 10 mg/kg + Ipilimumab 3 mg/kg (Part B1) n=8 Participants Combination CX-072 10 mg/kg + ipilimumab 3 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 10 mg/kg + Ipilimumab 6 mg/kg (Part B1) n=6 Participants Combination CX-072 10 mg/kg + ipilimumab 6 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 10 mg/kg + Ipilimumab 10 mg/kg (Part B1) n=1 Participants Combination CX-072 10 mg/kg + ipilimumab 10 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 3 mg/kg + Ipilimumab 3 mg/kg (Part B2) n=6 Participants Combination CX-072 3 mg/kg + ipilimumab 3 mg/kg (Part B2) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 10 mg/kg + Ipilimumab 3 mg/kg (Part B2) n=1 Participants Combination CX-072 3 mg/kg + ipilimumab 3 mg/kg (Part B2) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 1 mg/kg + Vemurafenib 960 mg (Part C) n=3 Participants Combination CX-072 1 mg/kg + Vemurafenib 960 mg (Part C) CX-072: Solution for infusion Vemurafenib: Tablet	CX-072 3 mg/kg + Vemurafenib 960 mg (Part C) n=6 Participants Combination CX-072 3 mg/kg + Vemurafenib 960 mg (Part C) CX-072: Solution for infusion Vemurafenib: Tablet	CX-072 10 mg/kg + Vemurafenib 960 mg (Part C) n=2 Participants Combination CX-072 10 mg/kg + Vemurafenib 960 mg (Part C) CX-072: Solution for infusion Vemurafenib: Tablet
The Number of Subjects Experiencing a Dose Limiting Toxicity (DLT) at Various Dose Levels When Given Multiple Doses of CX-072 as a Monotherapy or in Combination With Ipilimumab or Vemurafenib	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 2 years

Population: Per CX-072-001 Statistical Analysis Plan, efficacy analyses will be limited to subjects who received 10 mg/kg CX-072 as monotherapy during the study. This efficacy subset includes subjects from Parts A, A2 and D. Efficacy summaries will have parts A and A2 combined

The primary efficacy endpoint, ORR, was defined as the proportion of subjects with complete response (CR) or partial response (PR) on two consecutive tumor assessments according to RECIST v1.1.

Outcome measures

Outcome measures
Measure	CX-072 0.03 mg/kg (Part A and Part A2) n=16 Participants Monotherapy CX-072 0.03 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 0.1 mg/kg (Part A and Part A2) n=98 Participants Monotherapy CX-072 0.1 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 0.3 mg/kg (Part A and Part A2) Monotherapy CX-072 0.3 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 1 mg/kg (Part A and A2) Monotherapy CX-072 1 mg/kg (Part A and A2) CX-072: Solution for infusion	CX-072 3 mg/kg (Part A and Part A2) Monotherapy CX-072 3 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 10 mg/kg (Part A and Part A2) Monotherapy CX-072 10 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 30 mg/kg (Part A and Part A2) Monotherapy CX-072 30 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 0.3 mg/kg + Ipilimumab 3 mg/kg (Part B1) Combination CX-072 0.3 mg/kg + ipilimumab 3 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 1 mg/kg + Ipilimumab 3 mg/kg (Part B1) Combination CX-072 1 mg/kg + ipilimumab 3 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 3 mg/kg + Ipilimumab 3 mg/kg (Part B1) Combination CX-072 3 mg/kg + ipilimumab 3 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 10 mg/kg + Ipilimumab 3 mg/kg (Part B1) Combination CX-072 10 mg/kg + ipilimumab 3 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 10 mg/kg + Ipilimumab 6 mg/kg (Part B1) Combination CX-072 10 mg/kg + ipilimumab 6 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 10 mg/kg + Ipilimumab 10 mg/kg (Part B1) Combination CX-072 10 mg/kg + ipilimumab 10 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 3 mg/kg + Ipilimumab 3 mg/kg (Part B2) Combination CX-072 3 mg/kg + ipilimumab 3 mg/kg (Part B2) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 10 mg/kg + Ipilimumab 3 mg/kg (Part B2) Combination CX-072 3 mg/kg + ipilimumab 3 mg/kg (Part B2) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 1 mg/kg + Vemurafenib 960 mg (Part C) Combination CX-072 1 mg/kg + Vemurafenib 960 mg (Part C) CX-072: Solution for infusion Vemurafenib: Tablet	CX-072 3 mg/kg + Vemurafenib 960 mg (Part C) Combination CX-072 3 mg/kg + Vemurafenib 960 mg (Part C) CX-072: Solution for infusion Vemurafenib: Tablet	CX-072 10 mg/kg + Vemurafenib 960 mg (Part C) Combination CX-072 10 mg/kg + Vemurafenib 960 mg (Part C) CX-072: Solution for infusion Vemurafenib: Tablet
The Percentage of Subjects Experiencing Anti-cancer Activity (ORR) When Given 10 mg/kg CX-072 as Monotherapy	1 Participants	13 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Adverse Events

CX-072 0.03 mg/kg (Part A and Part A2)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 2 deaths

CX-072 0.1 mg/kg (Part A and Part A2)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 2 deaths

CX-072 0.3 mg/kg (Part A and Part A2)

Serious events: 3 serious events

Other events: 8 other events

Deaths: 5 deaths

CX-072 1 mg/kg (Part A and Part A2)

Serious events: 3 serious events

Other events: 9 other events

Deaths: 4 deaths

CX-072 3 mg/kg (Part A and Part A2)

Serious events: 7 serious events

Other events: 13 other events

Deaths: 9 deaths

CX-072 10 mg/kg (Part A and Part A2)

Serious events: 8 serious events

Other events: 16 other events

Deaths: 13 deaths

CX-072 30 mg/kg (Part A and Part A2)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 3 deaths

CX-072 0.3 mg/kg + Ipilimumab 3 mg/kg (Part B1)

Serious events: 3 serious events

Other events: 6 other events

Deaths: 5 deaths

CX-072 1 mg/kg + Ipilimumab 3 mg/kg (Part B1)

Serious events: 3 serious events

Other events: 3 other events

Deaths: 2 deaths

CX-072 3 mg/kg + Ipilimumab 3 mg/kg (Part B1)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 2 deaths

CX-072 10 mg/kg + Ipilimumab 3 mg/kg (Part B1)

Serious events: 4 serious events

Other events: 7 other events

Deaths: 4 deaths

CX-072 10 mg/kg + Ipilimumab 6 mg/kg (Part B1)

Serious events: 3 serious events

Other events: 6 other events

Deaths: 1 deaths

CX-072 10 mg/kg + Ipilimumab 10 mg/kg (Part B1)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

CX-072 3 mg/kg + Ipilimumab 3 mg/kg (Part B2)

Serious events: 3 serious events

Other events: 6 other events

Deaths: 4 deaths

CX-072 10 mg/kg + Ipilimumab 3 mg/kg (Part B2)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

CX-072 1 mg/kg + Vemurafenib 960 mg (Part C)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 3 deaths

CX-072 3 mg/kg + Vemurafenib 960 mg (Part C)

Serious events: 5 serious events

Other events: 6 other events

Deaths: 5 deaths

CX-072 10 mg/kg + Vemurafenib 960 mg (Part C)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

CX-072 10mg/kg Expansion (Part D)

Serious events: 33 serious events

Other events: 94 other events

Deaths: 50 deaths

Serious adverse events

Serious adverse events
Measure	CX-072 0.03 mg/kg (Part A and Part A2) n=2 participants at risk Monotherapy CX-072 0.03 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 0.1 mg/kg (Part A and Part A2) n=2 participants at risk Monotherapy CX-072 0.1 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 0.3 mg/kg (Part A and Part A2) n=8 participants at risk Monotherapy CX-072 0.3 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 1 mg/kg (Part A and Part A2) n=9 participants at risk Monotherapy CX-072 1 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 3 mg/kg (Part A and Part A2) n=13 participants at risk Monotherapy CX-072 3 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 10 mg/kg (Part A and Part A2) n=16 participants at risk Monotherapy CX-072 10 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 30 mg/kg (Part A and Part A2) n=3 participants at risk Monotherapy CX-072 30 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 0.3 mg/kg + Ipilimumab 3 mg/kg (Part B1) n=6 participants at risk Combination CX-072 0.3 mg/kg + ipilimumab 3 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 1 mg/kg + Ipilimumab 3 mg/kg (Part B1) n=3 participants at risk Combination CX-072 1 mg/kg + ipilimumab 3 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 3 mg/kg + Ipilimumab 3 mg/kg (Part B1) n=3 participants at risk Combination CX-072 3 mg/kg + ipilimumab 3 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 10 mg/kg + Ipilimumab 3 mg/kg (Part B1) n=8 participants at risk Combination CX-072 10 mg/kg + ipilimumab 3 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 10 mg/kg + Ipilimumab 6 mg/kg (Part B1) n=6 participants at risk Combination CX-072 10 mg/kg + ipilimumab 6 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 10 mg/kg + Ipilimumab 10 mg/kg (Part B1) n=1 participants at risk Combination CX-072 10 mg/kg + ipilimumab 10 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 3 mg/kg + Ipilimumab 3 mg/kg (Part B2) n=6 participants at risk Combination CX-072 3 mg/kg + ipilimumab 3 mg/kg (Part B2) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 10 mg/kg + Ipilimumab 3 mg/kg (Part B2) n=1 participants at risk Combination CX-072 3 mg/kg + ipilimumab 3 mg/kg (Part B2) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 1 mg/kg + Vemurafenib 960 mg (Part C) n=3 participants at risk Combination CX-072 1 mg/kg + Vemurafenib 960 mg (Part C) CX-072: Solution for infusion Vemurafenib: Tablet	CX-072 3 mg/kg + Vemurafenib 960 mg (Part C) n=6 participants at risk Combination CX-072 3 mg/kg + Vemurafenib 960 mg (Part C) CX-072: Solution for infusion Vemurafenib: Tablet	CX-072 10 mg/kg + Vemurafenib 960 mg (Part C) n=2 participants at risk Combination CX-072 10 mg/kg + Vemurafenib 960 mg (Part C) CX-072: Solution for infusion Vemurafenib: Tablet	CX-072 10mg/kg Expansion (Part D) n=98 participants at risk CX-072 10mg/kg monotherapy expansion (Part D)
Cardiac disorders Stress cardiomyopathy	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Infections and infestations Lower respiratory tract infection	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
Infections and infestations Abdominal wall abscess	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Infections and infestations Abscess	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Infections and infestations Diverticulitis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Infections and infestations Pneumonia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	4.1% 4/98 • Number of events 4 • 2 years
Infections and infestations Respiratory tract infection	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Infections and infestations Sepsis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
Infections and infestations Urinary tract infection	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Gastrointestinal disorders Diarrhoea	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	12.5% 2/16 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Gastrointestinal disorders Anal haemorrhage	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Gastrointestinal disorders Enterocutaneous fistula	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Gastrointestinal disorders Intestinal obstruction	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Gastrointestinal disorders Vomiting	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Gastrointestinal disorders Abdominal pain	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Gastrointestinal disorders Colitis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Gastrointestinal disorders Ileus	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Gastrointestinal disorders Pancreatitis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Infections and infestations Cellulitis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
Infections and infestations Escherichia bacteraemia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Infections and infestations Infection	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Infections and infestations COVID-19	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Infections and infestations Skin infection	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Cardiac disorders Atrial fibrillation	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Cardiac disorders Pericardial effusion	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
Cardiac disorders Supraventricular tachycardia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Cardiac disorders Cardiopulmonary failure	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Cardiac disorders Myocardial infarction	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Cardiac disorders Myocarditis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Renal and urinary disorders Acute kidney injury	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Renal and urinary disorders Nephrolithiasis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Renal and urinary disorders Urinary tract obstruction	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Metabolism and nutrition disorders Dehydration	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
General disorders Pyrexia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Investigations Alanine aminotransferase increased	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Investigations Aspartate aminotransferase increased	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Vascular disorders Deep vein thrombosis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Blood and lymphatic system disorders Anaemia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 3 • 2 years
Blood and lymphatic system disorders Neutropenia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Nervous system disorders Guillain-Barre syndrome	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Nervous system disorders Somnolence	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Endocrine disorders Hypophysitis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Reproductive system and breast disorders Testicular pain	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
General disorders Fatigue	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • 2 years
Investigations Blood creatinine increased	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Blood and lymphatic system disorders Blood loss anaemia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Blood and lymphatic system disorders Lymph node haemorrhage	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	50.0% 1/2 • Number of events 1 • 2 years	0.00% 0/98 • 2 years
Investigations Blood bilirubin increased	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Skin and subcutaneous tissue disorders Rash	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Vascular disorders Thrombosis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	50.0% 1/2 • Number of events 1 • 2 years	0.00% 0/98 • 2 years
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	3.1% 3/98 • Number of events 3 • 2 years
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Respiratory, thoracic and mediastinal disorders Immune-mediated pneumonitis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Renal and urinary disorders Renal failure	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
General disorders Chest discomfort	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Metabolism and nutrition disorders Decreased appetite	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 2 • 2 years
Nervous system disorders Cerebral ischaemia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Nervous system disorders Seizure	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Nervous system disorders Spinal cord compression	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Blood and lymphatic system disorders Leukocytosis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour obstruction	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Hepatobiliary disorders Haemobilia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Immune system disorders Hypersensitivity	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years

Other adverse events

Other adverse events
Measure	CX-072 0.03 mg/kg (Part A and Part A2) n=2 participants at risk Monotherapy CX-072 0.03 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 0.1 mg/kg (Part A and Part A2) n=2 participants at risk Monotherapy CX-072 0.1 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 0.3 mg/kg (Part A and Part A2) n=8 participants at risk Monotherapy CX-072 0.3 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 1 mg/kg (Part A and Part A2) n=9 participants at risk Monotherapy CX-072 1 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 3 mg/kg (Part A and Part A2) n=13 participants at risk Monotherapy CX-072 3 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 10 mg/kg (Part A and Part A2) n=16 participants at risk Monotherapy CX-072 10 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 30 mg/kg (Part A and Part A2) n=3 participants at risk Monotherapy CX-072 30 mg/kg (Part A and Part A2) CX-072: Solution for infusion	CX-072 0.3 mg/kg + Ipilimumab 3 mg/kg (Part B1) n=6 participants at risk Combination CX-072 0.3 mg/kg + ipilimumab 3 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 1 mg/kg + Ipilimumab 3 mg/kg (Part B1) n=3 participants at risk Combination CX-072 1 mg/kg + ipilimumab 3 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 3 mg/kg + Ipilimumab 3 mg/kg (Part B1) n=3 participants at risk Combination CX-072 3 mg/kg + ipilimumab 3 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 10 mg/kg + Ipilimumab 3 mg/kg (Part B1) n=8 participants at risk Combination CX-072 10 mg/kg + ipilimumab 3 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 10 mg/kg + Ipilimumab 6 mg/kg (Part B1) n=6 participants at risk Combination CX-072 10 mg/kg + ipilimumab 6 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 10 mg/kg + Ipilimumab 10 mg/kg (Part B1) n=1 participants at risk Combination CX-072 10 mg/kg + ipilimumab 10 mg/kg (Part B1) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 3 mg/kg + Ipilimumab 3 mg/kg (Part B2) n=6 participants at risk Combination CX-072 3 mg/kg + ipilimumab 3 mg/kg (Part B2) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 10 mg/kg + Ipilimumab 3 mg/kg (Part B2) n=1 participants at risk Combination CX-072 3 mg/kg + ipilimumab 3 mg/kg (Part B2) CX-072: Solution for infusion Ipilimumab: Solution for infusion	CX-072 1 mg/kg + Vemurafenib 960 mg (Part C) n=3 participants at risk Combination CX-072 1 mg/kg + Vemurafenib 960 mg (Part C) CX-072: Solution for infusion Vemurafenib: Tablet	CX-072 3 mg/kg + Vemurafenib 960 mg (Part C) n=6 participants at risk Combination CX-072 3 mg/kg + Vemurafenib 960 mg (Part C) CX-072: Solution for infusion Vemurafenib: Tablet	CX-072 10 mg/kg + Vemurafenib 960 mg (Part C) n=2 participants at risk Combination CX-072 10 mg/kg + Vemurafenib 960 mg (Part C) CX-072: Solution for infusion Vemurafenib: Tablet	CX-072 10mg/kg Expansion (Part D) n=98 participants at risk CX-072 10mg/kg monotherapy expansion (Part D)
Investigations Cachexia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Nervous system disorders Dysgeusia	50.0% 1/2 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
Nervous system disorders Headache	0.00% 0/2 • 2 years	50.0% 1/2 • Number of events 1 • 2 years	25.0% 2/8 • Number of events 3 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	6.2% 1/16 • Number of events 3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	66.7% 2/3 • Number of events 5 • 2 years	0.00% 0/3 • 2 years	25.0% 2/8 • Number of events 4 • 2 years	33.3% 2/6 • Number of events 4 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	100.0% 1/1 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	12.2% 12/98 • Number of events 13 • 2 years
Immune system disorders Contrast media reaction	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Blood and lymphatic system disorders Lymph node pain	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	33.3% 1/3 • Number of events 2 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Blood and lymphatic system disorders Anaemia	50.0% 1/2 • Number of events 2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	30.8% 4/13 • Number of events 5 • 2 years	25.0% 4/16 • Number of events 5 • 2 years	66.7% 2/3 • Number of events 2 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	37.5% 3/8 • Number of events 3 • 2 years	0.00% 0/6 • 2 years	100.0% 1/1 • Number of events 1 • 2 years	33.3% 2/6 • Number of events 2 • 2 years	0.00% 0/1 • 2 years	66.7% 2/3 • Number of events 6 • 2 years	33.3% 2/6 • Number of events 2 • 2 years	50.0% 1/2 • Number of events 1 • 2 years	24.5% 24/98 • Number of events 40 • 2 years
Blood and lymphatic system disorders Leukocytosis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 2 • 2 years	6.2% 1/16 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Cardiac disorders Atrial fibrillation	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
Cardiac disorders Bundle branch block right	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Cardiac disorders Palpitations	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Cardiac disorders Sinus tachycardia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	15.4% 2/13 • Number of events 3 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Cardiac disorders Supraventricular tachycardia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Cardiac disorders Tachycardia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Endocrine disorders Hypothyroidism	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	4.1% 4/98 • Number of events 4 • 2 years
Eye disorders Amaurosis fugax	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 2 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Eye disorders Diplopia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Eye disorders Dry eye	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	50.0% 1/2 • Number of events 1 • 2 years	0.00% 0/98 • 2 years
Eye disorders Vision blurred	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	4.1% 4/98 • Number of events 4 • 2 years
Eye disorders Vitreous floaters	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Gastrointestinal disorders Abdominal distension	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	12.5% 2/16 • Number of events 3 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	100.0% 1/1 • Number of events 1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	4.1% 4/98 • Number of events 4 • 2 years
Gastrointestinal disorders Abdominal pain	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	15.4% 2/13 • Number of events 3 • 2 years	12.5% 2/16 • Number of events 4 • 2 years	0.00% 0/3 • 2 years	33.3% 2/6 • Number of events 3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	25.0% 2/8 • Number of events 2 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	100.0% 1/1 • Number of events 1 • 2 years	33.3% 2/6 • Number of events 3 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	50.0% 1/2 • Number of events 1 • 2 years	7.1% 7/98 • Number of events 9 • 2 years
Gastrointestinal disorders Abdominal pain upper	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	33.3% 2/6 • Number of events 3 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	8.2% 8/98 • Number of events 9 • 2 years
Gastrointestinal disorders Anal haemorrhage	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Gastrointestinal disorders Ascites	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Gastrointestinal disorders Breath odour	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Gastrointestinal disorders Constipation	0.00% 0/2 • 2 years	50.0% 1/2 • Number of events 1 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	44.4% 4/9 • Number of events 4 • 2 years	30.8% 4/13 • Number of events 4 • 2 years	12.5% 2/16 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	33.3% 2/6 • Number of events 2 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	100.0% 1/1 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	14.3% 14/98 • Number of events 17 • 2 years
Gastrointestinal disorders Diarrhoea	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 4 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	18.8% 3/16 • Number of events 4 • 2 years	33.3% 1/3 • Number of events 2 • 2 years	33.3% 2/6 • Number of events 2 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	33.3% 2/6 • Number of events 3 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 3 • 2 years	100.0% 1/1 • Number of events 1 • 2 years	66.7% 2/3 • Number of events 2 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	26.5% 26/98 • Number of events 38 • 2 years
Gastrointestinal disorders Dry mouth	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	6.2% 1/16 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	4.1% 4/98 • Number of events 5 • 2 years
Gastrointestinal disorders Dyspepsia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	15.4% 2/13 • Number of events 2 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
Gastrointestinal disorders Dysphagia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
Gastrointestinal disorders Gastritis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Gastrointestinal disorders Haemorrhoids	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Gastrointestinal disorders Nausea	50.0% 1/2 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	25.0% 2/8 • Number of events 4 • 2 years	22.2% 2/9 • Number of events 2 • 2 years	38.5% 5/13 • Number of events 6 • 2 years	25.0% 4/16 • Number of events 6 • 2 years	0.00% 0/3 • 2 years	66.7% 4/6 • Number of events 6 • 2 years	100.0% 3/3 • Number of events 4 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 3 • 2 years	83.3% 5/6 • Number of events 8 • 2 years	0.00% 0/1 • 2 years	66.7% 4/6 • Number of events 4 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	22.4% 22/98 • Number of events 28 • 2 years
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 2 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Gastrointestinal disorders Stomatitis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	5.1% 5/98 • Number of events 5 • 2 years
Gastrointestinal disorders Vomiting	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	33.3% 2/6 • Number of events 4 • 2 years	0.00% 0/2 • 2 years	17.3% 17/98 • Number of events 22 • 2 years
General disorders Asthenia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	23.1% 3/13 • Number of events 3 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	66.7% 2/3 • Number of events 3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	3.1% 3/98 • Number of events 3 • 2 years
General disorders Axillary pain	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
General disorders Catheter site pain	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
General disorders Chest discomfort	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
General disorders Chills	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	4.1% 4/98 • Number of events 5 • 2 years
General disorders Early Satiety	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
General disorders Fatigue	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	50.0% 4/8 • Number of events 7 • 2 years	22.2% 2/9 • Number of events 2 • 2 years	30.8% 4/13 • Number of events 5 • 2 years	37.5% 6/16 • Number of events 7 • 2 years	0.00% 0/3 • 2 years	50.0% 3/6 • Number of events 4 • 2 years	66.7% 2/3 • Number of events 3 • 2 years	0.00% 0/3 • 2 years	25.0% 2/8 • Number of events 5 • 2 years	16.7% 1/6 • Number of events 2 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 5 • 2 years	100.0% 1/1 • Number of events 1 • 2 years	33.3% 1/3 • Number of events 5 • 2 years	33.3% 2/6 • Number of events 2 • 2 years	0.00% 0/2 • 2 years	33.7% 33/98 • Number of events 45 • 2 years
General disorders Influenza like illness	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 7 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	3.1% 3/98 • Number of events 6 • 2 years
General disorders Malaise	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
General disorders Non-cardiac chest pain	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	25.0% 2/8 • Number of events 5 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	3.1% 3/98 • Number of events 3 • 2 years
General disorders Oedema	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	5.1% 5/98 • Number of events 5 • 2 years
General disorders Oedema Peripheral	0.00% 0/2 • 2 years	50.0% 1/2 • Number of events 1 • 2 years	12.5% 1/8 • Number of events 2 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	0.00% 0/13 • 2 years	12.5% 2/16 • Number of events 5 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	25.0% 2/8 • Number of events 3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	9.2% 9/98 • Number of events 11 • 2 years
General disorders Pain	50.0% 1/2 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	4.1% 4/98 • Number of events 4 • 2 years
General disorders Peripheral swelling	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
General disorders Pyrexia	50.0% 1/2 • Number of events 3 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	7.7% 1/13 • Number of events 2 • 2 years	12.5% 2/16 • Number of events 2 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 2 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	11.2% 11/98 • Number of events 12 • 2 years
General disorders Localised Oedema	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
General disorders Chest Pain	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
General disorders Cyst	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
General disorders Facial Pain	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 2 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
General disorders Injection site bruising	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
General disorders Injection site mass	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Immune system disorders Hypersensitivity	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Immune system disorders Infusion related hypersensitivity reaction	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Infections and infestations Conjunctivitis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Infections and infestations Diverticulitis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Infections and infestations Epididymitis	50.0% 1/2 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Infections and infestations Gastroenteritis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Infections and infestations Herpes simplex reactivation	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Infections and infestations Laryngitis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Infections and infestations Lower respiratory tract infection	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 3 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	5.1% 5/98 • Number of events 5 • 2 years
Infections and infestations Oral candidiasis	50.0% 1/2 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
Infections and infestations Peritonitis bacterial	50.0% 1/2 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Infections and infestations Pneumonia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	33.3% 2/6 • Number of events 2 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	5.1% 5/98 • Number of events 8 • 2 years
Infections and infestations Skin infection	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 3 • 2 years
Infections and infestations Upper respiratory tract infection	50.0% 1/2 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	12.5% 2/16 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 2 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	10.2% 10/98 • Number of events 16 • 2 years
Infections and infestations Urinary tract infection	50.0% 1/2 • Number of events 2 • 2 years	0.00% 0/2 • 2 years	25.0% 2/8 • Number of events 2 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	100.0% 1/1 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	11.2% 11/98 • Number of events 12 • 2 years
Infections and infestations Viral infection	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 2 • 2 years
Infections and infestations Cellulitis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	4.1% 4/98 • Number of events 5 • 2 years
Infections and infestations Clostridium difficile infection	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Infections and infestations Fungal skin infection	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Infections and infestations Gastroenteritis viral	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	16.7% 1/6 • Number of events 2 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Infections and infestations Genital herpes	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Infections and infestations Nasopharyngitis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	66.7% 2/3 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
Infections and infestations Penile infection	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Infections and infestations Sialoadenitis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Infections and infestations Viral upper respiratory tract infection	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Infections and infestations Conjunctivitis bacterial	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Infections and infestations Ear infection	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Infections and infestations Genital candidiasis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Infections and infestations Mastoiditis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Infections and infestations Petrositis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Infections and infestations Pharyngitis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Infections and infestations Pyelonephritis acute	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Infections and infestations Respiratory tract infection viral	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	33.3% 2/6 • Number of events 2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Infections and infestations Rhinitis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Infections and infestations Vestibular neuronitis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Injury, poisoning and procedural complications Allergic transfusion reaction	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Injury, poisoning and procedural complications Fall	50.0% 1/2 • Number of events 2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	4.1% 4/98 • Number of events 4 • 2 years
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	37.5% 3/8 • Number of events 7 • 2 years	11.1% 1/9 • Number of events 3 • 2 years	23.1% 3/13 • Number of events 10 • 2 years	18.8% 3/16 • Number of events 6 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	25.0% 2/8 • Number of events 3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	33.3% 1/3 • Number of events 7 • 2 years	33.3% 2/6 • Number of events 6 • 2 years	50.0% 1/2 • Number of events 1 • 2 years	6.1% 6/98 • Number of events 13 • 2 years
Injury, poisoning and procedural complications Chillblains	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Injury, poisoning and procedural complications Contusion	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Injury, poisoning and procedural complications Procedural pain	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
Injury, poisoning and procedural complications Skin laceration	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Injury, poisoning and procedural complications Poisoning	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	33.3% 1/3 • Number of events 2 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Injury, poisoning and procedural complications Sunburn	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Investigations Alanine aminotransferase increased	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 2 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	66.7% 2/3 • Number of events 5 • 2 years	0.00% 0/8 • 2 years	16.7% 1/6 • Number of events 2 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	100.0% 1/1 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	50.0% 1/2 • Number of events 1 • 2 years	14.3% 14/98 • Number of events 15 • 2 years
Investigations Amylase increased	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 3 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	33.3% 1/3 • Number of events 3 • 2 years	12.5% 1/8 • Number of events 3 • 2 years	33.3% 2/6 • Number of events 2 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	50.0% 1/2 • Number of events 1 • 2 years	6.1% 6/98 • Number of events 9 • 2 years
Investigations Aspartate aminotransferase increased	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	33.3% 1/3 • Number of events 2 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	33.3% 2/6 • Number of events 5 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	100.0% 1/1 • Number of events 3 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	50.0% 1/2 • Number of events 1 • 2 years	23.5% 23/98 • Number of events 35 • 2 years
Investigations Blood alkaline phosphatase increased	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	22.2% 2/9 • Number of events 2 • 2 years	0.00% 0/13 • 2 years	18.8% 3/16 • Number of events 4 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	100.0% 1/1 • Number of events 1 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	50.0% 1/2 • Number of events 1 • 2 years	9.2% 9/98 • Number of events 11 • 2 years
Investigations Blood bicarbonate increased	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Investigations Blood lactate dehydrogenase increased	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	50.0% 1/2 • Number of events 1 • 2 years	0.00% 0/98 • 2 years
Investigations Cardiac murmur	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Investigations Electrocardiogram QT prolonged	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
Investigations Gamma-glutamyl transferase increased	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	12.5% 2/16 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	100.0% 1/1 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 3 • 2 years
Investigations Hepatic enzyme increased	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Investigations Neutrophil count decreased	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 5 • 2 years
Investigations Platelet count decreased	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 2 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	3.1% 3/98 • Number of events 4 • 2 years
Investigations Weight decreased	50.0% 1/2 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 2 • 2 years	6.2% 1/16 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	100.0% 1/1 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	33.3% 2/6 • Number of events 2 • 2 years	0.00% 0/2 • 2 years	12.2% 12/98 • Number of events 18 • 2 years
Investigations Weight Increased	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 2 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Investigations White blood cell count decreased	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 2 • 2 years
Investigations Blood bilirubin increased	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 5 • 2 years	0.00% 0/1 • 2 years	66.7% 2/3 • Number of events 3 • 2 years	50.0% 3/6 • Number of events 7 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Investigations Blood creatinine increased	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	100.0% 1/1 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	10.2% 10/98 • Number of events 20 • 2 years
Investigations Body temperature increased	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Investigations Globulins increased	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Investigations Lipase increased	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	12.5% 1/8 • Number of events 2 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	66.7% 2/3 • Number of events 3 • 2 years	16.7% 1/6 • Number of events 2 • 2 years	50.0% 1/2 • Number of events 4 • 2 years	8.2% 8/98 • Number of events 13 • 2 years
Investigations Transaminases increased	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 2 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Investigations Blood thyroid stimulating hormone decreased	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	100.0% 1/1 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Investigations Blood albumin decreased	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Investigations Creatinine renal clearance decreased	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Investigations Heart rate increased	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Investigations Protein total decreased	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Infections and infestations Candida infection	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Metabolism and nutrition disorders Decreased appetite	50.0% 1/2 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	37.5% 3/8 • Number of events 3 • 2 years	44.4% 4/9 • Number of events 5 • 2 years	23.1% 3/13 • Number of events 3 • 2 years	25.0% 4/16 • Number of events 7 • 2 years	0.00% 0/3 • 2 years	33.3% 2/6 • Number of events 2 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	25.0% 2/8 • Number of events 2 • 2 years	33.3% 2/6 • Number of events 2 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	66.7% 2/3 • Number of events 3 • 2 years	33.3% 2/6 • Number of events 2 • 2 years	0.00% 0/2 • 2 years	23.5% 23/98 • Number of events 25 • 2 years
Metabolism and nutrition disorders Dehydration	50.0% 1/2 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	37.5% 3/8 • Number of events 3 • 2 years	44.4% 4/9 • Number of events 5 • 2 years	23.1% 3/13 • Number of events 3 • 2 years	25.0% 4/16 • Number of events 7 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	25.0% 2/8 • Number of events 2 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	100.0% 1/1 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	6.1% 6/98 • Number of events 7 • 2 years
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	22.2% 2/9 • Number of events 2 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	33.3% 1/3 • Number of events 2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	5.1% 5/98 • Number of events 5 • 2 years
Metabolism and nutrition disorders Hyperkalaemia	50.0% 1/2 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 2 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 2 • 2 years
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	12.5% 2/16 • Number of events 2 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	7.1% 7/98 • Number of events 7 • 2 years
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	3.1% 3/98 • Number of events 3 • 2 years
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 3 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	12.5% 2/16 • Number of events 3 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	33.3% 2/6 • Number of events 4 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	3.1% 3/98 • Number of events 4 • 2 years
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 2 • 2 years	7.7% 1/13 • Number of events 2 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 3 • 2 years	0.00% 0/3 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/8 • 2 years	33.3% 2/6 • Number of events 2 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	6.1% 6/98 • Number of events 8 • 2 years
Metabolism and nutrition disorders Hyponatraemia	50.0% 1/2 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	22.2% 2/9 • Number of events 4 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	12.5% 2/16 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	7.1% 7/98 • Number of events 9 • 2 years
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 2 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Metabolism and nutrition disorders Gout	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	6.1% 6/98 • Number of events 10 • 2 years
Metabolism and nutrition disorders Increased appetite	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/2 • 2 years	50.0% 1/2 • Number of events 1 • 2 years	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	15.4% 2/13 • Number of events 4 • 2 years	12.5% 2/16 • Number of events 2 • 2 years	66.7% 2/3 • Number of events 2 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	25.0% 2/8 • Number of events 2 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	33.3% 2/6 • Number of events 2 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	33.3% 2/6 • Number of events 2 • 2 years	50.0% 1/2 • Number of events 4 • 2 years	12.2% 12/98 • Number of events 15 • 2 years
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/2 • 2 years	50.0% 1/2 • Number of events 1 • 2 years	25.0% 2/8 • Number of events 2 • 2 years	0.00% 0/9 • 2 years	23.1% 3/13 • Number of events 3 • 2 years	18.8% 3/16 • Number of events 3 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	100.0% 1/1 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	11.2% 11/98 • Number of events 13 • 2 years
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	3.1% 3/98 • Number of events 6 • 2 years
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Musculoskeletal and connective tissue disorders Muscle spasms	50.0% 1/2 • Number of events 4 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	5.1% 5/98 • Number of events 5 • 2 years
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	15.4% 2/13 • Number of events 2 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	33.3% 2/6 • Number of events 2 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	5.1% 5/98 • Number of events 5 • 2 years
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	5.1% 5/98 • Number of events 7 • 2 years
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	33.3% 2/6 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	8.2% 8/98 • Number of events 9 • 2 years
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	11.1% 1/9 • Number of events 2 • 2 years	0.00% 0/13 • 2 years	12.5% 2/16 • Number of events 2 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	33.3% 2/6 • Number of events 3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	8.2% 8/98 • Number of events 12 • 2 years
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	15.4% 2/13 • Number of events 2 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 2 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	15.4% 2/13 • Number of events 3 • 2 years	12.5% 2/16 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	33.3% 2/6 • Number of events 4 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Musculoskeletal and connective tissue disorders Trigger finger	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Musculoskeletal and connective tissue disorders Metastases to meninges	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Musculoskeletal and connective tissue disorders Papilloma	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Musculoskeletal and connective tissue disorders Skin papilloma	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	33.3% 1/3 • Number of events 2 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Nervous system disorders Cerebrovascular accident	0.00% 0/2 • 2 years	50.0% 1/2 • Number of events 1 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Nervous system disorders Dizziness	50.0% 1/2 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	15.4% 2/13 • Number of events 2 • 2 years	12.5% 2/16 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	6.1% 6/98 • Number of events 6 • 2 years
Nervous system disorders Dizziness exertional	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Nervous system disorders Hypoaesthesia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	22.2% 2/9 • Number of events 2 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Nervous system disorders Lethargy	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
Nervous system disorders Metabolic encephalopathy	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Nervous system disorders Migraine with aura	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Nervous system disorders Neuropathy peripheral	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	3.1% 3/98 • Number of events 4 • 2 years
Nervous system disorders Paraesthesia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	100.0% 1/1 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 3 • 2 years
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Nervous system disorders Poor quality sleep	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Nervous system disorders Sciatica	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 2 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 2 • 2 years
Nervous system disorders Syncope	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Nervous system disorders Presyncope	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Nervous system disorders Seizure	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	33.3% 1/3 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Nervous system disorders Somnolence	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
Nervous system disorders Vasogenic cerebral oedema	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Nervous system disorders Autonomic nervous system imbalance	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Nervous system disorders Complex regional pain syndrome	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	33.3% 1/3 • Number of events 2 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Nervous system disorders Facial paresis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Nervous system disorders Taste disorder	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Nervous system disorders Vascular encephalopathy	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Psychiatric disorders Anxiety	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Psychiatric disorders Confusional state	50.0% 1/2 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 2 • 2 years
Psychiatric disorders Depression	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
Psychiatric disorders Emotional distress	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Psychiatric disorders Insomnia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	12.5% 2/16 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	33.3% 2/6 • Number of events 2 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	4.1% 4/98 • Number of events 5 • 2 years
Psychiatric disorders Mental status changes	0.00% 0/2 • 2 years	50.0% 1/2 • Number of events 1 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Psychiatric disorders Hallucination	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	100.0% 1/1 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Renal and urinary disorders Acute kidney injury	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Renal and urinary disorders Haematuria	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	15.4% 2/13 • Number of events 2 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 2 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Renal and urinary disorders Hydronephrosis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Renal and urinary disorders Postrenal failure	50.0% 1/2 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Renal and urinary disorders Urinary incontinence	50.0% 1/2 • Number of events 1 • 2 years	50.0% 1/2 • Number of events 1 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Renal and urinary disorders Urinary retention	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 2 • 2 years
Renal and urinary disorders Urinary tract pain	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Renal and urinary disorders Choluria	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Renal and urinary disorders Dysuria	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Renal and urinary disorders Haemoglobinuria	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Renal and urinary disorders Renal impairment	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Reproductive system and breast disorders Breast swelling	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Reproductive system and breast disorders Pelvic pain	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 2 • 2 years
Reproductive system and breast disorders Vaginal discharge	50.0% 1/2 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	100.0% 1/1 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Reproductive system and breast disorders Vulvovaginal pain	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Reproductive system and breast disorders Penile pain	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	44.4% 4/9 • Number of events 5 • 2 years	30.8% 4/13 • Number of events 4 • 2 years	25.0% 4/16 • Number of events 4 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	33.3% 2/6 • Number of events 4 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	16.3% 16/98 • Number of events 18 • 2 years
Respiratory, thoracic and mediastinal disorders Dry Throat	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	33.3% 1/3 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	3.1% 3/98 • Number of events 3 • 2 years
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	30.8% 4/13 • Number of events 6 • 2 years	25.0% 4/16 • Number of events 4 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	25.0% 2/8 • Number of events 3 • 2 years	0.00% 0/6 • 2 years	100.0% 1/1 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	15.3% 15/98 • Number of events 18 • 2 years
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Respiratory, thoracic and mediastinal disorders Epistaxis	50.0% 1/2 • Number of events 2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	12.5% 2/16 • Number of events 3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	66.7% 2/3 • Number of events 2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	100.0% 1/1 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 3 • 2 years	0.00% 0/3 • 2 years	33.3% 2/6 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	33.3% 2/6 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 3 • 2 years
Respiratory, thoracic and mediastinal disorders Tracheal pain	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	33.3% 2/6 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	66.7% 2/3 • Number of events 2 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Skin and subcutaneous tissue disorders Erythema	0.00% 0/2 • 2 years	50.0% 1/2 • Number of events 1 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	3.1% 3/98 • Number of events 3 • 2 years
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	3.1% 3/98 • Number of events 3 • 2 years
Skin and subcutaneous tissue disorders Pruritus	50.0% 1/2 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	25.0% 2/8 • Number of events 2 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	12.5% 2/16 • Number of events 9 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	50.0% 4/8 • Number of events 13 • 2 years	66.7% 4/6 • Number of events 7 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	50.0% 3/6 • Number of events 3 • 2 years	0.00% 0/2 • 2 years	7.1% 7/98 • Number of events 7 • 2 years
Skin and subcutaneous tissue disorders Rash	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	33.3% 1/3 • Number of events 5 • 2 years	66.7% 2/3 • Number of events 4 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	66.7% 2/3 • Number of events 3 • 2 years	66.7% 4/6 • Number of events 9 • 2 years	50.0% 1/2 • Number of events 2 • 2 years	14.3% 14/98 • Number of events 18 • 2 years
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/2 • 2 years	50.0% 1/2 • Number of events 1 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	37.5% 3/8 • Number of events 4 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	50.0% 1/2 • Number of events 2 • 2 years	3.1% 3/98 • Number of events 6 • 2 years
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Skin and subcutaneous tissue disorders Skin ulcer	50.0% 1/2 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Skin and subcutaneous tissue disorders Tumour pruritus	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Skin and subcutaneous tissue disorders Erythema ab igne	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	100.0% 1/1 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	33.3% 1/3 • Number of events 2 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Vascular disorders Deep vein thrombosis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Vascular disorders Hot flush	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 2 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	5.1% 5/98 • Number of events 5 • 2 years
Vascular disorders Hypertension	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	6.2% 1/16 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	33.3% 2/6 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	8.2% 8/98 • Number of events 10 • 2 years
Vascular disorders Hypotension	50.0% 1/2 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years	7.7% 1/13 • Number of events 1 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Vascular disorders Embolism	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	33.3% 2/6 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Vascular disorders Haematoma	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Vascular disorders Phlebitis superficial	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	16.7% 1/6 • Number of events 2 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Vascular disorders Lymphostasis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	33.3% 1/3 • Number of events 2 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Ear and labyrinth disorders Deafness unilateral	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Ear and labyrinth disorders Deafness neurosensory	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Gastrointestinal disorders Abdominal tenderness	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Gastrointestinal disorders Colitis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Hepatobiliary disorders Cholecystitis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 5 • 2 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Hepatobiliary disorders Cholelithiasis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Hepatobiliary disorders Immune-medicated hepatitis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Hepatobiliary disorders Hepatomegaly	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
General disorders Hyperbilirubinaemia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Blood and lymphatic system disorders Lymphopenia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Blood and lymphatic system disorders Neutropenia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 5 • 2 years
Endocrine disorders Hyperthyroidism	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	25.0% 2/8 • Number of events 2 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
Eye disorders Conjunctivitis allergic	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Eye disorders Eye pain	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Gastrointestinal disorders Eructation	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Gastrointestinal disorders Lip Pain	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Gastrointestinal disorders Lip ulceration	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Gastrointestinal disorders Toothache	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Nervous system disorders Akathisia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Nervous system disorders Aphasia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Nervous system disorders Cognitive disorder	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	33.3% 1/3 • Number of events 4 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Nervous system disorders Encephalopathy	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Nervous system disorders Guillain-Barre syndrome	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Psychiatric disorders Agitation	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Psychiatric disorders Apathy	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	33.3% 1/3 • Number of events 3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 2 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Ear and labyrinth disorders Tinnitus	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Blood and lymphatic system disorders Blood loss anaemia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 1 • 2 years
Blood and lymphatic system disorders Eosinophilia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	33.3% 1/3 • Number of events 1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Blood and lymphatic system disorders Leukopenia	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	50.0% 1/2 • Number of events 1 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
Blood and lymphatic system disorders Lymph node haemorrhage	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	33.3% 1/3 • Number of events 4 • 2 years	0.00% 0/6 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Blood and lymphatic system disorders Lymphocytosis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Cardiac disorders Coronary artery disease	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Endocrine disorders Empty sella syndrome	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Eye disorders Keratitis	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	1.0% 1/98 • Number of events 5 • 2 years
Gastrointestinal disorders Abdominal discomfort	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	2.0% 2/98 • Number of events 2 • 2 years
Gastrointestinal disorders Abdominal pain lower	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	16.7% 1/6 • Number of events 1 • 2 years	0.00% 0/2 • 2 years	0.00% 0/98 • 2 years
Gastrointestinal disorders Oral pain	0.00% 0/2 • 2 years	0.00% 0/2 • 2 years	0.00% 0/8 • 2 years	0.00% 0/9 • 2 years	0.00% 0/13 • 2 years	0.00% 0/16 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	0.00% 0/3 • 2 years	0.00% 0/3 • 2 years	0.00% 0/8 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/6 • 2 years	0.00% 0/1 • 2 years	0.00% 0/3 • 2 years	0.00% 0/6 • 2 years	50.0% 1/2 • Number of events 1 • 2 years	0.00% 0/98 • 2 years

Additional Information

Head of Clinical Operations

CytomX Therapeutics, Inc.

Phone: (650) 515-3185

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place