Trial Outcomes & Findings for Continuous Infusion of rhIL-15 for Adults With Advanced Cancer (NCT NCT01572493)

Last Updated: 2023-03-06

Results Overview

The MTD is the dose level at which less than one-third of patients (0/3 or 0-1/6 participants) treated at that dose experience a dose-limiting toxicity (DLT), with the next higher dose level demonstrating a one-third or greater number of participants (≥ 2/3 or ≥ 2/6 participants) having DLT. A DLT is Grade 2 diarrhea lasting more than 24 hours or any grade 3 or 4 toxicity, if deemed possibly, probably or definitely related to the study drug by the principal investigator during the first cycle of treatment. Toxicities were assessed by the Common Terminology Criteria for Adverse Events (CTCAE)v4. Grade 3 is severe, and Grade 4 is life-threatening.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

38 participants

Primary outcome timeframe

After one cycle (one cycle is 42 days for 10-day dosing)

Results posted on

2023-03-06

Participant Flow

No participants were enrolled in the dose expansion phase of the study.

Participant milestones

Participant milestones
Measure	Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days Level 1 - 0.1 mcg/kg/day x 10 Days	Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days Level 2 - 0.25 mcg/kg/day x 10 Days	Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days Level 3 - 0.5 mcg/kg/day x 10 Days	Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days Level 4 - 1 mcg/kg/day x 10 Days	Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days Level 5 - 2 mcg/kg/day x 10 Days	Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days Level 6 - 4 mcg/kg/day x 10 Days	Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days Level 7 - 3 mcg/kg/day x 5 Days	Dose Escalation Level 8 - 4 mcg/kg/Day x 5 Days Level 8 - 4 mcg/kg/day x 5 Days	Dose Escalation Level 9 - 5 mcg/kg/Day x 5 Days Level 9 - 5 mcg/kg/day x 5 Days
Overall Study STARTED	4	3	3	6	9	2	4	3	4
Overall Study COMPLETED	3	2	1	4	7	1	1	3	2
Overall Study NOT COMPLETED	1	1	2	2	2	1	3	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days Level 1 - 0.1 mcg/kg/day x 10 Days	Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days Level 2 - 0.25 mcg/kg/day x 10 Days	Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days Level 3 - 0.5 mcg/kg/day x 10 Days	Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days Level 4 - 1 mcg/kg/day x 10 Days	Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days Level 5 - 2 mcg/kg/day x 10 Days	Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days Level 6 - 4 mcg/kg/day x 10 Days	Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days Level 7 - 3 mcg/kg/day x 5 Days	Dose Escalation Level 9 - 5 mcg/kg/Day x 5 Days Level 9 - 5 mcg/kg/day x 5 Days
Overall Study Physician Decision	1	0	0	0	0	0	0	0
Overall Study Switched to alternative treatment	0	1	2	1	2	0	2	2
Overall Study Death	0	0	0	1	0	1	0	0
Overall Study Adverse Event	0	0	0	0	0	0	1	0

Baseline Characteristics

Continuous Infusion of rhIL-15 for Adults With Advanced Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days n=4 Participants Level 1 - 0.1 mcg/kg/day x 10 Days	Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days n=3 Participants Level 2 - 0.25 mcg/kg/day x 10 Days	Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days n=3 Participants Level 3 - 0.5 mcg/kg/day x 10 Days	Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days n=6 Participants Level 4 - 1 mcg/kg/day x 10 Days	Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days n=9 Participants Level 5 - 2 mcg/kg/day x 10 Days	Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days n=2 Participants Level 6 - 4 mcg/kg/day x 10 Days	Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days n=4 Participants Level 7 - 3 mcg/kg/day x 5 Days	Dose Escalation Level 8 - 4 mcg/kg/Day x 5 Days n=3 Participants Level 8 - 4 mcg/kg/day x 5 Days	Dose Escalation Level 9 - 5 mcg/kg/Day x 5 Days n=4 Participants Level 9 - 5 mcg/kg/day x 5 Days	Total n=38 Participants Total of all reporting groups
Age, Categorical <=18 years	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
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=8 Participants	2 Participants n=8 Participants	2 Participants n=24 Participants	3 Participants n=42 Participants	24 Participants n=42 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	14 Participants n=42 Participants
Age, Continuous	66.63 years STANDARD_DEVIATION 5.11 • n=5 Participants	51.97 years STANDARD_DEVIATION 7.26 • n=7 Participants	55.83 years STANDARD_DEVIATION 18.4 • n=5 Participants	55.05 years STANDARD_DEVIATION 5.82 • n=4 Participants	56.58 years STANDARD_DEVIATION 12.89 • n=21 Participants	62.75 years STANDARD_DEVIATION 2.33 • n=8 Participants	60.05 years STANDARD_DEVIATION 10.92 • n=8 Participants	60.9 years STANDARD_DEVIATION 5.42 • n=24 Participants	61.15 years STANDARD_DEVIATION 7.42 • n=42 Participants	58.48 years STANDARD_DEVIATION 9.8 • n=42 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	7 Participants n=21 Participants	1 Participants n=8 Participants	4 Participants n=8 Participants	1 Participants n=24 Participants	2 Participants n=42 Participants	21 Participants n=42 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	2 Participants n=24 Participants	2 Participants n=42 Participants	17 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	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
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	9 Participants n=21 Participants	2 Participants n=8 Participants	4 Participants n=8 Participants	3 Participants n=24 Participants	4 Participants n=42 Participants	34 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 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	4 Participants n=42 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
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	3 Participants n=42 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
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	5 Participants n=42 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	6 Participants n=21 Participants	2 Participants n=8 Participants	4 Participants n=8 Participants	2 Participants n=24 Participants	4 Participants n=42 Participants	29 Participants n=42 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
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	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	1 Participants n=42 Participants
Region of Enrollment United States	4 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	6 participants n=4 Participants	9 participants n=21 Participants	2 participants n=8 Participants	4 participants n=8 Participants	3 participants n=24 Participants	4 participants n=42 Participants	38 participants n=42 Participants
Diagnosis Head and Neck cancer	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants
Diagnosis Sarcoma	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 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	4 Participants n=42 Participants
Diagnosis Renal Cell carcinoma	0 Participants n=5 Participants	2 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	1 Participants n=24 Participants	0 Participants n=42 Participants	4 Participants n=42 Participants
Diagnosis Pancreatic cancer	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	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants
Diagnosis Colorectal cancer	1 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	3 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	7 Participants n=42 Participants
Diagnosis Metastatic Melanoma	1 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	3 Participants n=42 Participants
Diagnosis Non-Small Cell Lung cancer (NSCLC)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Diagnosis Endometrial	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Diagnosis Adrenal	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Diagnosis Adenoid Cystic	0 Participants n=5 Participants	0 Participants n=7 Participants	1 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	1 Participants n=42 Participants
Diagnosis Cholangiocarcinoma	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Diagnosis Gastric neuro-ectodermal	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	1 Participants n=42 Participants
Diagnosis Prostate	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Diagnosis Gastrointestinal Stromal Tumor	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	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Diagnosis Small bowel	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	1 Participants n=42 Participants	1 Participants n=42 Participants
Diagnosis Esophageal	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	1 Participants n=24 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants
Performance Status - Eastern Cooperative Oncology Group (ECOG) 0	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
Performance Status - Eastern Cooperative Oncology Group (ECOG) 1	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	9 Participants n=21 Participants	2 Participants n=8 Participants	4 Participants n=8 Participants	3 Participants n=24 Participants	4 Participants n=42 Participants	38 Participants n=42 Participants
Prior Therapy Surgery	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=8 Participants	4 Participants n=8 Participants	2 Participants n=24 Participants	3 Participants n=42 Participants	26 Participants n=42 Participants
Prior Therapy Chemotherapy	3 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=8 Participants	4 Participants n=8 Participants	3 Participants n=24 Participants	3 Participants n=42 Participants	28 Participants n=42 Participants
Prior Therapy Radiation Therapy	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	18 Participants n=42 Participants
Prior Therapy Molecular Therapy	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
Prior Therapy Immunotherapy	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	3 Participants n=24 Participants	1 Participants n=42 Participants	14 Participants n=42 Participants
Prior Therapy Checkpoint Inhibitors	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
Prior Therapy Hormonal Therapy	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	1 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	4 Participants n=42 Participants

PRIMARY outcome

Timeframe: After one cycle (one cycle is 42 days for 10-day dosing)

Outcome measures

Outcome measures
Measure	All Participants n=27 Participants All participants on the following dose levels: Level 1 - 0.1 mcg/kg/day x 10 Days Level 2 - 0.25 mcg/kg/day x 10 Days Level 3 - 0.5 mcg/kg/day x 10 Days Level 4 - 1 mcg/kg/day x 10 Days Level 5 - 2 mcg/kg/day x 10 Days Level 6 - 4 mcg/kg/day x 10 Days	Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days Level 2 - 0.25 mcg/kg/day x 10 Days	Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days Level 3 - 0.5 mcg/kg/day x 10 Days	Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days Level 4 - 1 mcg/kg/day x 10 Days	Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days Level 5 - 2 mcg/kg/day x 10 Days	Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days Level 6 - 4 mcg/kg/day x 10 Days	Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days Level 7 - 3 mcg/kg/day x 5 Days	Dose Escalation Level 8 - 4 mcg/kg/Day x 5 Days Level 8 - 4 mcg/kg/day x 5 Days	Dose Escalation Level 9 - 5 mcg/kg/Day x 5 Days Level 9 - 5 mcg/kg/day x 5 Days
Maximum Tolerated Dose (MTD) of Recombinant Human Interleukin-15 (rhIL-15) for 10 Day Dosing	2 mcg/kg/day	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: After one cycle (one cycle is 21 days for 5-day dosing)

Outcome measures

Outcome measures
Measure	All Participants n=9 Participants All participants on the following dose levels: Level 1 - 0.1 mcg/kg/day x 10 Days Level 2 - 0.25 mcg/kg/day x 10 Days Level 3 - 0.5 mcg/kg/day x 10 Days Level 4 - 1 mcg/kg/day x 10 Days Level 5 - 2 mcg/kg/day x 10 Days Level 6 - 4 mcg/kg/day x 10 Days	Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days Level 2 - 0.25 mcg/kg/day x 10 Days	Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days Level 3 - 0.5 mcg/kg/day x 10 Days	Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days Level 4 - 1 mcg/kg/day x 10 Days	Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days Level 5 - 2 mcg/kg/day x 10 Days	Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days Level 6 - 4 mcg/kg/day x 10 Days	Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days Level 7 - 3 mcg/kg/day x 5 Days	Dose Escalation Level 8 - 4 mcg/kg/Day x 5 Days Level 8 - 4 mcg/kg/day x 5 Days	Dose Escalation Level 9 - 5 mcg/kg/Day x 5 Days Level 9 - 5 mcg/kg/day x 5 Days
Maximum Tolerated Dose (MTD) of Recombinant Human Interleukin-15 (rhIL-15) for 5 Day Dosing	NA mcg/kg/day The protocol stated that only if there was a clinical response in the 5-day cohorts, would a dose expansion cohort (and additional higher doses) be attempted. By this time about 70 participants had received the NCI rhIL-15 and there were no clinical responses and participants at the 4 and 5 mcg/kg/day were starting to demonstrate (non-DLT) pulmonary toxicity. So we had the information we needed for the "RPh2 dose."	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: After one cycle (one cycle is either 42 or 21 days)

A DLT is Grade 2 diarrhea lasting more than 24 hours or any grade 3 or 4 toxicity, if deemed possibly, probable or definitely related to the study drug by the principal investigator during the first cycle of treatment; and/or Grade 5 death related to adverse event. Toxicities were assessed by the Common Terminology Criteria for Adverse Events (CTCAE)v4. Grade 3 is severe, and Grade 4 is life-threatening.

Outcome measures

Outcome measures
Measure	All Participants n=4 Participants All participants on the following dose levels: Level 1 - 0.1 mcg/kg/day x 10 Days Level 2 - 0.25 mcg/kg/day x 10 Days Level 3 - 0.5 mcg/kg/day x 10 Days Level 4 - 1 mcg/kg/day x 10 Days Level 5 - 2 mcg/kg/day x 10 Days Level 6 - 4 mcg/kg/day x 10 Days	Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days n=3 Participants Level 2 - 0.25 mcg/kg/day x 10 Days	Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days n=3 Participants Level 3 - 0.5 mcg/kg/day x 10 Days	Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days n=6 Participants Level 4 - 1 mcg/kg/day x 10 Days	Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days n=9 Participants Level 5 - 2 mcg/kg/day x 10 Days	Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days n=2 Participants Level 6 - 4 mcg/kg/day x 10 Days	Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days n=4 Participants Level 7 - 3 mcg/kg/day x 5 Days	Dose Escalation Level 8 - 4 mcg/kg/Day x 5 Days n=3 Participants Level 8 - 4 mcg/kg/day x 5 Days	Dose Escalation Level 9 - 5 mcg/kg/Day x 5 Days n=4 Participants Level 9 - 5 mcg/kg/day x 5 Days
Number of Participants With Grades 3, 4 or 5 Dose-Limiting Toxicity (DLT) Related to Study Drug Grade 3	2 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grades 3, 4 or 5 Dose-Limiting Toxicity (DLT) Related to Study Drug Grade 4	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grades 3, 4 or 5 Dose-Limiting Toxicity (DLT) Related to Study Drug Grade 5	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Both cycles 1 and 2 (each cycle is 42 days) for the 10 day treatment, up to 84 days. And clinical responses for the 5-day treatment cohorts (21 day cycle length) were assessed after cycles 2, 4, 6, 8 and so on treatment cycles.

Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, and the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Outcome measures

Outcome measures
Measure	All Participants n=4 Participants All participants on the following dose levels: Level 1 - 0.1 mcg/kg/day x 10 Days Level 2 - 0.25 mcg/kg/day x 10 Days Level 3 - 0.5 mcg/kg/day x 10 Days Level 4 - 1 mcg/kg/day x 10 Days Level 5 - 2 mcg/kg/day x 10 Days Level 6 - 4 mcg/kg/day x 10 Days	Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days n=3 Participants Level 2 - 0.25 mcg/kg/day x 10 Days	Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days n=3 Participants Level 3 - 0.5 mcg/kg/day x 10 Days	Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days n=6 Participants Level 4 - 1 mcg/kg/day x 10 Days	Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days n=9 Participants Level 5 - 2 mcg/kg/day x 10 Days	Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days n=2 Participants Level 6 - 4 mcg/kg/day x 10 Days	Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days n=4 Participants Level 7 - 3 mcg/kg/day x 5 Days	Dose Escalation Level 8 - 4 mcg/kg/Day x 5 Days n=3 Participants Level 8 - 4 mcg/kg/day x 5 Days	Dose Escalation Level 9 - 5 mcg/kg/Day x 5 Days n=4 Participants Level 9 - 5 mcg/kg/day x 5 Days
Clinical Response Rate Complete Response	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Response Rate Partial Response	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Response Rate Progressive Disease	1 Participants	3 Participants	1 Participants	2 Participants	3 Participants	2 Participants	1 Participants	2 Participants	3 Participants
Clinical Response Rate Stable Disease	2 Participants	0 Participants	2 Participants	3 Participants	4 Participants	0 Participants	2 Participants	1 Participants	0 Participants
Clinical Response Rate Not Assessed	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From the date of protocol consent until date of progressive disease is documented, up to 263 days

Population: One participant in dose level 1 and dose level 2, two participants in dose level 3, three participants in dose level 4, two participants in dose level 5, one participant in dose level 6 and dose level 7, and one participant in dose level 9 were not evaluable.

TTP is defined as the date of protocol consent until date of progressive disease is documented. Progressive disease was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, and the appearance of one or more new lesions.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants on the following dose levels: Level 1 - 0.1 mcg/kg/day x 10 Days Level 2 - 0.25 mcg/kg/day x 10 Days Level 3 - 0.5 mcg/kg/day x 10 Days Level 4 - 1 mcg/kg/day x 10 Days Level 5 - 2 mcg/kg/day x 10 Days Level 6 - 4 mcg/kg/day x 10 Days	Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days n=2 Participants Level 2 - 0.25 mcg/kg/day x 10 Days	Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days n=1 Participants Level 3 - 0.5 mcg/kg/day x 10 Days	Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days n=3 Participants Level 4 - 1 mcg/kg/day x 10 Days	Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days n=7 Participants Level 5 - 2 mcg/kg/day x 10 Days	Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days n=1 Participants Level 6 - 4 mcg/kg/day x 10 Days	Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days n=3 Participants Level 7 - 3 mcg/kg/day x 5 Days	Dose Escalation Level 8 - 4 mcg/kg/Day x 5 Days n=3 Participants Level 8 - 4 mcg/kg/day x 5 Days	Dose Escalation Level 9 - 5 mcg/kg/Day x 5 Days n=3 Participants Level 9 - 5 mcg/kg/day x 5 Days
Time to Progression (TTP)	74 Days Interval 28.0 to 138.0	54 Days Interval 37.0 to 71.0	29 Days Data is for a single participant.	77 Days Interval 70.0 to 263.0	68 Days Interval 30.0 to 74.0	6 Days Data is for a single participant.	87 Days Interval 49.0 to 91.0	42 Days Interval 42.0 to 74.0	34.5 Days Interval 9.0 to 42.0

SECONDARY outcome

Timeframe: Prior to 1st dose, at 10 minutes after 1st dose, once daily on days 7-10 at completion of treatment, at 10 and 30 minutes after completion of treatment and at 1, 2, 4, and approximately 24 hours after completion of treatment.

Population: 3/4 participants in dose level 1, and 2/3 participants in dose level 2 were not evaluable for this outcome measure. Cmax was only performed for the 10 day dosing cohorts.

The maximum observed analyte concentration in serum was reported.

Outcome measures

Outcome measures
Measure	All Participants n=1 Participants All participants on the following dose levels: Level 1 - 0.1 mcg/kg/day x 10 Days Level 2 - 0.25 mcg/kg/day x 10 Days Level 3 - 0.5 mcg/kg/day x 10 Days Level 4 - 1 mcg/kg/day x 10 Days Level 5 - 2 mcg/kg/day x 10 Days Level 6 - 4 mcg/kg/day x 10 Days	Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days n=1 Participants Level 2 - 0.25 mcg/kg/day x 10 Days	Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days n=3 Participants Level 3 - 0.5 mcg/kg/day x 10 Days	Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days n=6 Participants Level 4 - 1 mcg/kg/day x 10 Days	Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days n=9 Participants Level 5 - 2 mcg/kg/day x 10 Days	Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days n=2 Participants Level 6 - 4 mcg/kg/day x 10 Days	Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days Level 7 - 3 mcg/kg/day x 5 Days	Dose Escalation Level 8 - 4 mcg/kg/Day x 5 Days Level 8 - 4 mcg/kg/day x 5 Days	Dose Escalation Level 9 - 5 mcg/kg/Day x 5 Days Level 9 - 5 mcg/kg/day x 5 Days
Maximum Observed Plasma Concentration (Cmax) of Recombinant Human Interleukin-15 (rhIL-15)	51 pg/mL Geometric Coefficient of Variation NA Cannot determine geometric coefficient of variation value with one participant.	59 pg/mL Geometric Coefficient of Variation NA Cannot determine geometric coefficient of variation value with one participant.	116 pg/mL Geometric Coefficient of Variation 72	1413 pg/mL Geometric Coefficient of Variation 1478	5662 pg/mL Geometric Coefficient of Variation 5961	26852 pg/mL Geometric Coefficient of Variation 11374	—	—	—

SECONDARY outcome

Timeframe: Days 7 through 10

Population: 3/4 participants in dose level 1, and 2/3 participants in dose level 2 were not evaluable for this outcome measure. Css was only performed for the 10 day dosing cohorts.

Concentration of drug in plasma at steady state (Css).

Outcome measures

Outcome measures
Measure	All Participants n=1 Participants All participants on the following dose levels: Level 1 - 0.1 mcg/kg/day x 10 Days Level 2 - 0.25 mcg/kg/day x 10 Days Level 3 - 0.5 mcg/kg/day x 10 Days Level 4 - 1 mcg/kg/day x 10 Days Level 5 - 2 mcg/kg/day x 10 Days Level 6 - 4 mcg/kg/day x 10 Days	Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days n=1 Participants Level 2 - 0.25 mcg/kg/day x 10 Days	Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days n=3 Participants Level 3 - 0.5 mcg/kg/day x 10 Days	Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days n=6 Participants Level 4 - 1 mcg/kg/day x 10 Days	Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days n=9 Participants Level 5 - 2 mcg/kg/day x 10 Days	Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days n=2 Participants Level 6 - 4 mcg/kg/day x 10 Days	Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days Level 7 - 3 mcg/kg/day x 5 Days	Dose Escalation Level 8 - 4 mcg/kg/Day x 5 Days Level 8 - 4 mcg/kg/day x 5 Days	Dose Escalation Level 9 - 5 mcg/kg/Day x 5 Days Level 9 - 5 mcg/kg/day x 5 Days
Concentration of Drug in Plasma at Steady State (Css)	44.5 pg/mL Geometric Coefficient of Variation NA Cannot determine geometric coefficient of variation value with one participant.	48.5 pg/mL Geometric Coefficient of Variation NA Cannot determine geometric coefficient of variation value with one participant.	73.2 pg/mL Geometric Coefficient of Variation 22.6	489 pg/mL Geometric Coefficient of Variation 463	2020 pg/mL Geometric Coefficient of Variation 2309	9562 pg/mL Geometric Coefficient of Variation 59.35	—	—	—

SECONDARY outcome

Population: 3/4 participants in dose level 1, and 2/3 participants in dose level 2 were not evaluable for this outcome measure. AUClast was only performed for the 10 day dosing cohorts.

AUClast is from dosing to the time of the last measured concentration \>/= lower limit of quantitation (LLOQ)(Clast) of that dosing period.

Outcome measures

Outcome measures
Measure	All Participants n=1 Participants All participants on the following dose levels: Level 1 - 0.1 mcg/kg/day x 10 Days Level 2 - 0.25 mcg/kg/day x 10 Days Level 3 - 0.5 mcg/kg/day x 10 Days Level 4 - 1 mcg/kg/day x 10 Days Level 5 - 2 mcg/kg/day x 10 Days Level 6 - 4 mcg/kg/day x 10 Days	Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days n=1 Participants Level 2 - 0.25 mcg/kg/day x 10 Days	Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days n=3 Participants Level 3 - 0.5 mcg/kg/day x 10 Days	Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days n=6 Participants Level 4 - 1 mcg/kg/day x 10 Days	Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days n=9 Participants Level 5 - 2 mcg/kg/day x 10 Days	Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days n=2 Participants Level 6 - 4 mcg/kg/day x 10 Days	Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days Level 7 - 3 mcg/kg/day x 5 Days	Dose Escalation Level 8 - 4 mcg/kg/Day x 5 Days Level 8 - 4 mcg/kg/day x 5 Days	Dose Escalation Level 9 - 5 mcg/kg/Day x 5 Days Level 9 - 5 mcg/kg/day x 5 Days
Area Under the Curve (AUClast)	7756 pg/mL Geometric Coefficient of Variation NA Cannot determine geometric coefficient of variation value with one participant.	10907 pg/mL Geometric Coefficient of Variation NA Cannot determine geometric coefficient of variation value with one participant.	20798 pg/mL Geometric Coefficient of Variation 8667	187453 pg/mL Geometric Coefficient of Variation 206143	321747 pg/mL Geometric Coefficient of Variation 300686	262651 pg/mL Geometric Coefficient of Variation 77613	—	—	—

SECONDARY outcome

Timeframe: Pre, 0.16, 1, 2, 4, 8, 12, and 24 hours on Day 1. Days 2, 7, 8, 9, and 10. 0, 0.16, 0.32, 1, 2, 4, and 12 hours on Day 11. And 24 hours on Day 12.

Population: This outcome measure was only performed for 10 day dosing.

Serum samples was obtained from participants and inflammatory cytokine analyses was performed by flow cytometry to determine levels of Interleukin - 1, Interferon γ, Interleukin-6 and Tumor Necrosis Factor ἁ.

Outcome measures

Outcome measures
Measure	All Participants n=4 Participants All participants on the following dose levels: Level 1 - 0.1 mcg/kg/day x 10 Days Level 2 - 0.25 mcg/kg/day x 10 Days Level 3 - 0.5 mcg/kg/day x 10 Days Level 4 - 1 mcg/kg/day x 10 Days Level 5 - 2 mcg/kg/day x 10 Days Level 6 - 4 mcg/kg/day x 10 Days	Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days n=3 Participants Level 2 - 0.25 mcg/kg/day x 10 Days	Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days n=3 Participants Level 3 - 0.5 mcg/kg/day x 10 Days	Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days n=6 Participants Level 4 - 1 mcg/kg/day x 10 Days	Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days n=9 Participants Level 5 - 2 mcg/kg/day x 10 Days	Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days n=2 Participants Level 6 - 4 mcg/kg/day x 10 Days	Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days Level 7 - 3 mcg/kg/day x 5 Days	Dose Escalation Level 8 - 4 mcg/kg/Day x 5 Days Level 8 - 4 mcg/kg/day x 5 Days	Dose Escalation Level 9 - 5 mcg/kg/Day x 5 Days Level 9 - 5 mcg/kg/day x 5 Days
Inflammatory Cytokines Interleukin - 1, 12 hours on Day 11	NA pg/mL Standard Error NA tests not performed	0.81 pg/mL Standard Error 0.6	NA pg/mL Standard Error NA tests not performed	NA pg/mL Standard Error NA tests not performed	NA pg/mL Standard Error NA tests not performed	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interferon γ on Day 10	13.3 pg/mL Standard Error 16	8.9 pg/mL Standard Error 1.9	43 pg/mL Standard Error 10.7	262 pg/mL Standard Error 432	238 pg/mL Standard Error 214	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interleukin - 1, 8 hours on Day 1	0.73 pg/mL Standard Error 0.1	0.24 pg/mL Standard Error 0	1.3 pg/mL Standard Error 1.4	0.83 pg/mL Standard Error 0.8	209 pg/mL Standard Error 605	0.24 pg/mL Standard Error 0	—	—	—
Inflammatory Cytokines Interleukin - 1, 12 hours on Day 1	0.54 pg/mL Standard Error 0.2	0.24 pg/mL Standard Error 0	0.36 pg/mL Standard Error 0.2	0.5 pg/mL Standard Error 0.3	7 pg/mL Standard Error 19.7	0.24 pg/mL Standard Error 0	—	—	—
Inflammatory Cytokines Interleukin - 1, 24 hours on Day 1	0.36 pg/mL Standard Error 0.2	0.24 pg/mL Standard Error 0	0.62 pg/mL Standard Error 0.65	1.2 pg/mL Standard Error 1.4	4.3 pg/mL Standard Error 8	0.24 pg/mL Standard Error 0	—	—	—
Inflammatory Cytokines Interleukin - 1 on Day 2	0.42 pg/mL Standard Error 0.3	0.24 pg/mL Standard Error 0	0.94 pg/mL Standard Error 1.2	0.43 pg/mL Standard Error 0.3	1.1 pg/mL Standard Error 1.5	0.7 pg/mL Standard Error 0.6	—	—	—
Inflammatory Cytokines Interleukin - 1, Pre Day 1	0.38 pg/mL Standard Error 0.24	0.24 pg/mL Standard Error 0	9.8 pg/mL Standard Error 15.9	0.86 pg/mL Standard Error 0.8	0.34 pg/mL Standard Error 0.1	0.24 pg/mL Standard Error 0	—	—	—
Inflammatory Cytokines Interleukin - 1, 0.16 hours on Day 1	0.28 pg/mL Standard Error 0	0.24 pg/mL Standard Error 0	2.2 pg/mL Standard Error 3	19 pg/mL Standard Error 45	77 pg/mL Standard Error 229	0.24 pg/mL Standard Error 0	—	—	—
Inflammatory Cytokines Interleukin - 1, 1 hour on Day 1	0.47 pg/mL Standard Error 0.3	0.24 pg/mL Standard Error 0	17.9 pg/mL Standard Error 30	9.1 pg/mL Standard Error 20	57 pg/mL Standard Error 170	0.24 pg/mL Standard Error 0	—	—	—
Inflammatory Cytokines Interleukin - 1, 2 hours on Day 1	0.58 pg/mL Standard Error 0.3	0.24 pg/mL Standard Error 0	4.4 pg/mL Standard Error 6.8	3.5 pg/mL Standard Error 8	22 pg/mL Standard Error 65	0.24 pg/mL Standard Error 0	—	—	—
Inflammatory Cytokines Interleukin - 1, 4 hours on Day 1	0.59 pg/mL Standard Error 0.3	0.24 pg/mL Standard Error 0	13.4 pg/mL Standard Error 21	0.53 pg/mL Standard Error 0.3	6.3 pg/mL Standard Error 16	0.36 pg/mL Standard Error 0.2	—	—	—
Inflammatory Cytokines Interleukin - 1 on Day 7	1.18 pg/mL Standard Error 0.9	0.24 pg/mL Standard Error 0	0.44 pg/mL Standard Error 0.35	0.32 pg/mL Standard Error 0.1	0.27 pg/mL Standard Error 0.1	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interleukin - 1 on Day 8	0.43 pg/mL Standard Error 0.3	0.24 pg/mL Standard Error 0	0.25 pg/mL Standard Error 0.2	0.36 pg/mL Standard Error 0.3	0.29 pg/mL Standard Error 0.1	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interleukin - 1 on Day 9	0.54 pg/mL Standard Error 0.5	0.24 pg/mL Standard Error 0	0.76 pg/mL Standard Error 0.23	0.38 pg/mL Standard Error 0.3	0.42 pg/mL Standard Error 0.4	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interleukin - 1 on Day 10	0.45 pg/mL Standard Error 0.3	0.24 pg/mL Standard Error 0	0.59 pg/mL Standard Error 0.13	0.3 pg/mL Standard Error 0.1	0.37 pg/mL Standard Error 0.2	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interleukin - 1, 0 hours on Day 11	0.72 pg/mL Standard Error 0.8	0.27 pg/mL Standard Error 0	0.69 pg/mL Standard Error 0.21	1.1 pg/mL Standard Error 0.8	0.62 pg/mL Standard Error 0.6	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interleukin - 1, 0.16 hours on Day 11	0.62 pg/mL Standard Error 0.6	2.98 pg/mL Standard Error 4.7	0.64 pg/mL Standard Error 0.21	0.72 pg/mL Standard Error 0.4	0.61 pg/mL Standard Error 0.6	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interleukin - 1, 0.32 hours on Day 11	0.69 pg/mL Standard Error 0.7	0.26 pg/mL Standard Error 0.4	0.56 pg/mL Standard Error 0.16	0.65 pg/mL Standard Error 0.5	0.56 pg/mL Standard Error 0.4	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interleukin - 1, 1 hour on Day 11	8.69 pg/mL Standard Error 13.3	0.81 pg/mL Standard Error 0.9	0.45 pg/mL Standard Error 0.1	0.75 pg/mL Standard Error 0.6	0.6 pg/mL Standard Error 0.5	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interleukin - 1, 2 hours on Day 11	0.51 pg/mL Standard Error 0.3	0.24 pg/mL Standard Error 0	NA pg/mL Standard Error NA tests not performed	2.17 pg/mL Standard Error 1.7	0.52 pg/mL Standard Error 0.4	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interleukin - 1, 4 hours on Day 11	1.2 pg/mL Standard Error 1.1	0.32 pg/mL Standard Error 0.1	16.2 pg/mL Standard Error 0	0.75 pg/mL Standard Error 0.6	0.42 pg/mL Standard Error 0.3	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interleukin - 1, 24 hours on Day 12	0.44 pg/mL Standard Error 0.3	0.24 pg/mL Standard Error 0	16.2 pg/mL Standard Error 27	0.34 pg/mL Standard Error 0.1	0.27 pg/mL Standard Error 0.1	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interferon γ, Pre Day 1	6.8 pg/mL Standard Error 6.9	4.6 pg/mL Standard Error 1.6	8.3 pg/mL Standard Error 8.9	4.7 pg/mL Standard Error 3	9.2 pg/mL Standard Error 6.3	2.8 pg/mL Standard Error 1	—	—	—
Inflammatory Cytokines Interferon γ - 0.16 hours on Day 1	2.5 pg/mL Standard Error 1.6	3.4 pg/mL Standard Error 0.5	5.7 pg/mL Standard Error 4.7	17 pg/mL Standard Error 23	21 pg/mL Standard Error 40	1.72 pg/mL Standard Error 0	—	—	—
Inflammatory Cytokines Interferon γ - 1 hour on Day 1	6.5 pg/mL Standard Error 5.5	4 pg/mL Standard Error 1	8.4 pg/mL Standard Error 8	4 pg/mL Standard Error 3.3	10.6 pg/mL Standard Error 10	2.9 pg/mL Standard Error 1.9	—	—	—
Inflammatory Cytokines Interferon γ - 2 hours on Day 1	6.8 pg/mL Standard Error 5.9	4.7 pg/mL Standard Error 1.6	6.9 pg/mL Standard Error 4.4	4.5 pg/mL Standard Error 2.9	11.5 pg/mL Standard Error 7.2	7 pg/mL Standard Error 2	—	—	—
Inflammatory Cytokines Interferon γ - 4 hours on Day 1	9.4 pg/mL Standard Error 6.8	4.9 pg/mL Standard Error 1	6.8 pg/mL Standard Error 3.2	11 pg/mL Standard Error 7	131 pg/mL Standard Error 289	131 pg/mL Standard Error 3.3	—	—	—
Inflammatory Cytokines Interferon γ - 8 hours on Day 1	27 pg/mL Standard Error 14	5 pg/mL Standard Error 2.2	10.6 pg/mL Standard Error 6.5	24 pg/mL Standard Error 20	110 pg/mL Standard Error 170	97 pg/mL Standard Error 67	—	—	—
Inflammatory Cytokines Interferon γ - 12 hours on Day 1	22.7 pg/mL Standard Error 24	5.7 pg/mL Standard Error 2	11.2 pg/mL Standard Error 7.4	29 pg/mL Standard Error 14.7	66.6 pg/mL Standard Error 39	38.7 pg/mL Standard Error 13	—	—	—
Inflammatory Cytokines Interferon γ - 24 hours on Day 1	24.6 pg/mL Standard Error 34	6.6 pg/mL Standard Error 1.1	13.3 pg/mL Standard Error 8	32.8 pg/mL Standard Error 19	106 pg/mL Standard Error 84	94.6 pg/mL Standard Error 38	—	—	—
Inflammatory Cytokines Interferon γ on Day 2	11.1 pg/mL Standard Error 12	8.1 pg/mL Standard Error 2.3	17 pg/mL Standard Error 10.1	58.4 pg/mL Standard Error 47	230 pg/mL Standard Error 205	639 pg/mL Standard Error 678	—	—	—
Inflammatory Cytokines Interferon γ on Day 7	10 pg/mL Standard Error 10	8.6 pg/mL Standard Error 1.3	56 pg/mL Standard Error 55	43.8 pg/mL Standard Error 29	136 pg/mL Standard Error 74	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interferon γ on Day 8	13.2 pg/mL Standard Error 18	9.5 pg/mL Standard Error 0.4	55.7 pg/mL Standard Error 57	52.9 pg/mL Standard Error 36	145 pg/mL Standard Error 109	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interferon γ on Day 9	15 pg/mL Standard Error 20	8.9 pg/mL Standard Error 2.3	26.8 pg/mL Standard Error 21	132 pg/mL Standard Error 183	149 pg/mL Standard Error 112	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interferon γ - 0 hours on Day 11	11 pg/mL Standard Error 11.4	7.8 pg/mL Standard Error 1	57.4 pg/mL Standard Error 34	451 pg/mL Standard Error 794	315 pg/mL Standard Error 327	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interferon γ - 0.16 hours on Day 11	11.3 pg/mL Standard Error 12	7.7 pg/mL Standard Error 0.3	37.8 pg/mL Standard Error 6	99 pg/mL Standard Error 111	223 pg/mL Standard Error 180	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interferon γ - 0.32 hours on Day 11	11.6 pg/mL Standard Error 12	7.6 pg/mL Standard Error 0.5	41 pg/mL Standard Error 1.1	101 pg/mL Standard Error 123	207 pg/mL Standard Error 177	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interferon γ - 1 hour on Day 11	12 pg/mL Standard Error 12.4	7.5 pg/mL Standard Error 0.3	37.5 pg/mL Standard Error 4.7	106 pg/mL Standard Error 119	204 pg/mL Standard Error 172	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interferon γ - 2 hours on Day 11	8.6 pg/mL Standard Error 8	5.5 pg/mL Standard Error 0.5	25.3 pg/mL Standard Error 0.5	96.6 pg/mL Standard Error 93	101 pg/mL Standard Error 170	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interferon γ - 4 hours on Day 11	12.5 pg/mL Standard Error 13	7.6 pg/mL Standard Error 1.3	36.9 pg/mL Standard Error 10	89 pg/mL Standard Error 77	190 pg/mL Standard Error 141	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interferon γ - 12 hours on Day 11	NA pg/mL Standard Error NA tests not performed	NA pg/mL Standard Error NA tests not performed	NA pg/mL Standard Error NA tests not performed	NA pg/mL Standard Error NA tests not performed	NA pg/mL Standard Error NA tests not performed	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interferon γ - 24 hours on Day 12	8.3 pg/mL Standard Error 84.6	5.1 pg/mL Standard Error 0.2	19 pg/mL Standard Error 6.4	27.4 pg/mL Standard Error 27	97 pg/mL Standard Error 145	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interleukin-6, Pre Day 1	3.4 pg/mL Standard Error 2.6	5.3 pg/mL Standard Error 4.2	200 pg/mL Standard Error 342	2.1 pg/mL Standard Error 1.2	7.1 pg/mL Standard Error 9.6	4.6 pg/mL Standard Error 4.7	—	—	—
Inflammatory Cytokines Interleukin-6 - 0.16 hours on Day 1	3.4 pg/mL Standard Error 2.4	5.3 pg/mL Standard Error 3.7	348 pg/mL Standard Error 596	6.2 pg/mL Standard Error 6.4	232 pg/mL Standard Error 682	6.8 pg/mL Standard Error 0	—	—	—
Inflammatory Cytokines Interleukin-6 - 1 hour on Day 1	3.7 pg/mL Standard Error 3.8	5.2 pg/mL Standard Error 4.2	179 pg/mL Standard Error 303	3.7 pg/mL Standard Error 3.7	262 pg/mL Standard Error 773	3.9 pg/mL Standard Error 3.7	—	—	—
Inflammatory Cytokines Interleukin-6 - 2 hours on Day 1	4.1 pg/mL Standard Error 4.2	6.6 pg/mL Standard Error 5.4	18.1 pg/mL Standard Error 23	3.2 pg/mL Standard Error 2.2	120 pg/mL Standard Error 349	3.8 pg/mL Standard Error 3.5	—	—	—
Inflammatory Cytokines Interleukin-6 - 4 hours on Day 1	5.1 pg/mL Standard Error 4.3	6.9 pg/mL Standard Error 5.8	78 pg/mL Standard Error 127	2.9 pg/mL Standard Error 1.6	23.7 pg/mL Standard Error 30	45.6 pg/mL Standard Error 59	—	—	—
Inflammatory Cytokines Interleukin-6 - 8 hours on Day 1	3 pg/mL Standard Error 0.45	6.6 pg/mL Standard Error 5.4	4.9 pg/mL Standard Error 2.5	6.6 pg/mL Standard Error 3.4	607 pg/mL Standard Error 1767	16.9 pg/mL Standard Error 9.4	—	—	—
Inflammatory Cytokines Interleukin-6 - 12 hours on Day 1	6.3 pg/mL Standard Error 7	6.7 pg/mL Standard Error 5.9	4.4 pg/mL Standard Error 1.1	5.1 pg/mL Standard Error 3	18.4 pg/mL Standard Error 27	7.3 pg/mL Standard Error 4.8	—	—	—
Inflammatory Cytokines Interleukin-6 - 24 hours on Day 1	4 pg/mL Standard Error 2.3	7.2 pg/mL Standard Error 5.8	5.1 pg/mL Standard Error 3.2	4.7 pg/mL Standard Error 1.9	19 pg/mL Standard Error 24	12.7 pg/mL Standard Error 10	—	—	—
Inflammatory Cytokines Interleukin-6 on Day 2	2.2 pg/mL Standard Error 0.7	6.2 pg/mL Standard Error 4.5	6.2 pg/mL Standard Error 5.3	3.4 pg/mL Standard Error 1.7	13.2 pg/mL Standard Error 14	141 pg/mL Standard Error 112	—	—	—
Inflammatory Cytokines Interleukin-6 on Day 7	15.2 pg/mL Standard Error 17	4.8 pg/mL Standard Error 2.8	6.6 pg/mL Standard Error 4.9	3.2 pg/mL Standard Error 0.9	8 pg/mL Standard Error 7.2	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interleukin-6 on Day 8	4 pg/mL Standard Error 4.4	6.1 pg/mL Standard Error 4.1	2.9 pg/mL Standard Error 1.2	4.3 pg/mL Standard Error 1.9	8.8 pg/mL Standard Error 9.1	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interleukin-6 on Day 9	3.4 pg/mL Standard Error 2.5	6.8 pg/mL Standard Error 5.4	5.2 pg/mL Standard Error 5.2	4.7 pg/mL Standard Error 2	9.9 pg/mL Standard Error 9.2	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interleukin-6 on Day 10	3.8 pg/mL Standard Error 2.4	5.9 pg/mL Standard Error 4.7	3.1 pg/mL Standard Error 1	5.6 pg/mL Standard Error 3.1	12 pg/mL Standard Error 14	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interleukin-6 - 0 hours on Day 11	3.7 pg/mL Standard Error 2.4	7.7 pg/mL Standard Error 6.3	11.6 pg/mL Standard Error 12	7.1 pg/mL Standard Error 7.6	10.2 pg/mL Standard Error 8.6	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interleukin-6 - 0.16 hours on Day 11	3.6 pg/mL Standard Error 1.5	6.8 pg/mL Standard Error 6.2	16.3 pg/mL Standard Error 12.	7.9 pg/mL Standard Error 8.9	11.4 pg/mL Standard Error 9.7	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interleukin-6 - 0.32 hours on Day 11	3.4 pg/mL Standard Error 1.4	113 pg/mL Standard Error 184	19.7 pg/mL Standard Error 13	5.1 pg/mL Standard Error 1.8	11.4 pg/mL Standard Error 9.2	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interleukin-6 - 1 hour on Day 11	82 pg/mL Standard Error 136	6.8 pg/mL Standard Error 6.2	16 pg/mL Standard Error 13.5	5.1 pg/mL Standard Error 1.8	11.2 pg/mL Standard Error 8.9	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interleukin-6 - 2 hours on Day 11	5.5 pg/mL Standard Error 4	45.7 pg/mL Standard Error 66	14.6 pg/mL Standard Error 10.	12.2 pg/mL Standard Error 16	11.4 pg/mL Standard Error 10	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interleukin-6 - 4 hours on Day 11	3.7 pg/mL Standard Error 1.3	8.5 pg/mL Standard Error 7.6	13.3 pg/mL Standard Error 10	NA pg/mL Standard Error NA tests not performed	9.8 pg/mL Standard Error 8.8	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interleukin-6 - 12 hours on Day 11	NA pg/mL Standard Error NA tests not performed	NA pg/mL Standard Error NA tests not performed	NA pg/mL Standard Error NA tests not performed	NA pg/mL Standard Error NA tests not performed	NA pg/mL Standard Error NA tests not performed	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Interleukin-6 - 24 hours on Day 12	2.9 pg/mL Standard Error 0.7	7.7 pg/mL Standard Error 6.6	30.4 pg/mL Standard Error 27	3.3 pg/mL Standard Error 1.1	8.3 pg/mL Standard Error 9.38	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Tumor Necrosis Factor ἁ, Pre Day 1	1.85 pg/mL Standard Error 0.8	2.3 pg/mL Standard Error 0.5	12.4 pg/mL Standard Error 18	2.2 pg/mL Standard Error 0.9	2.4 pg/mL Standard Error 0.6	1.8 pg/mL Standard Error 0.5	—	—	—
Inflammatory Cytokines Tumor Necrosis Factor ἁ - 0.16 hours on Day 1	1.2 pg/mL Standard Error 0.4	1.7 pg/mL Standard Error 0.7	39 pg/mL Standard Error 66	3.40 pg/mL Standard Error 2	13.5 pg/mL Standard Error 34	1.9 pg/mL Standard Error 0	—	—	—
Inflammatory Cytokines Tumor Necrosis Factor ἁ - 1 hour on Day 1	1.7 pg/mL Standard Error 0.8	2.3 pg/mL Standard Error 1.2	24 pg/mL Standard Error 39	2.7 pg/mL Standard Error 1.7	11.2 pg/mL Standard Error 27	1.7 pg/mL Standard Error 0.4	—	—	—
Inflammatory Cytokines Tumor Necrosis Factor ἁ - 2 hours on Day 1	1.8 pg/mL Standard Error 1.0	2.4 pg/mL Standard Error 1.4	6.3 pg/mL Standard Error 8	2.5 pg/mL Standard Error 1	7.8 pg/mL Standard Error 15	2.5 pg/mL Standard Error 0.6	—	—	—
Inflammatory Cytokines Tumor Necrosis Factor ἁ - 4 hours on Day 1	2.7 pg/mL Standard Error 1.7	2.2 pg/mL Standard Error 1.1	16 pg/mL Standard Error 25	2.9 pg/mL Standard Error 1.2	5.5 pg/mL Standard Error 3.7	6 pg/mL Standard Error 1.2	—	—	—
Inflammatory Cytokines Tumor Necrosis Factor ἁ - 8 hours on Day 1	1.7 pg/mL Standard Error 0.5	2.4 pg/mL Standard Error 1.3	3.6 pg/mL Standard Error 2.2	4.3 pg/mL Standard Error 1.7	13.3 pg/mL Standard Error 20	6 pg/mL Standard Error 3	—	—	—
Inflammatory Cytokines Tumor Necrosis Factor ἁ - 12 hours on Day 1	2.5 pg/mL Standard Error 1	2.6 pg/mL Standard Error 1.2	3.9 pg/mL Standard Error 2.4	5 pg/mL Standard Error 1.9	8.6 pg/mL Standard Error 3.3	6.3 pg/mL Standard Error 0.5	—	—	—
Inflammatory Cytokines Tumor Necrosis Factor ἁ - 24 hours on Day 1	2.1 pg/mL Standard Error 0.5	2.9 pg/mL Standard Error 0.7	4.4 pg/mL Standard Error 3.3	6.4 pg/mL Standard Error 2.1	11.5 pg/mL Standard Error 6.4	9.2 pg/mL Standard Error 2.8	—	—	—
Inflammatory Cytokines Tumor Necrosis Factor ἁ Day 2	2.3 pg/mL Standard Error 0.7	3.6 pg/mL Standard Error 0.4	5.1 pg/mL Standard Error 2.8	6.8 pg/mL Standard Error 2.3	11.6 pg/mL Standard Error 4.7	24 pg/mL Standard Error 7	—	—	—
Inflammatory Cytokines Tumor Necrosis Factor ἁ on Day 7	2.9 pg/mL Standard Error 0.5	3 pg/mL Standard Error 1.2	5.5 pg/mL Standard Error 4.5	7.5 pg/mL Standard Error 2.1	13.8 pg/mL Standard Error 2.7	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Tumor Necrosis Factor ἁ on Day 8	2.7 pg/mL Standard Error 0.9	3.5 pg/mL Standard Error 1.5	5.6 pg/mL Standard Error 4.3	7.7 pg/mL Standard Error 2	13.4 pg/mL Standard Error 2.9	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Tumor Necrosis Factor ἁ on Day 9	2.6 pg/mL Standard Error 1.2	3.4 pg/mL Standard Error 1.6	5.3 pg/mL Standard Error 3.3	6.6 pg/mL Standard Error 2.7	11.2 pg/mL Standard Error 3.7	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Tumor Necrosis Factor ἁ on Day 10	2.7 pg/mL Standard Error 1.6	2.8 pg/mL Standard Error 1.4	5.6 pg/mL Standard Error 3.8	7.4 pg/mL Standard Error 2	11.1 pg/mL Standard Error 3.6	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Tumor Necrosis Factor ἁ - 0 hours on Day 11	2.4 pg/mL Standard Error 1.2	2.9 pg/mL Standard Error 1	6.3 pg/mL Standard Error 1.9	6.6 pg/mL Standard Error 1.7	10.7 pg/mL Standard Error 3	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Tumor Necrosis Factor ἁ - 0.16 hours on Day 11	2.2 pg/mL Standard Error 0.6	3 pg/mL Standard Error 1.2	4.7 pg/mL Standard Error 1.6	6.5 pg/mL Standard Error 1.6	9.8 pg/mL Standard Error 2.4	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Tumor Necrosis Factor ἁ - 0.32 hours on Day 11	2.5 pg/mL Standard Error 1.5	14.2 pg/mL Standard Error 20	5.5 pg/mL Standard Error 2.9	6 pg/mL Standard Error 1.3	9.4 pg/mL Standard Error 2.3	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Tumor Necrosis Factor ἁ - 1 hour on Day 11	4.4 pg/mL Standard Error 2.2	2.9 pg/mL Standard Error 0.9	4.9 pg/mL Standard Error 2.5	6.4 pg/mL Standard Error 1.7	9.7 pg/mL Standard Error 2.4	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Tumor Necrosis Factor ἁ - 2 hours on Day 11	1.9 pg/mL Standard Error 0.6	4 pg/mL Standard Error 3.8	4 pg/mL Standard Error 1.9	4.7 pg/mL Standard Error 3	9 pg/mL Standard Error 2.1	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Tumor Necrosis Factor ἁ - 4 hours on Day 11	2.7 pg/mL Standard Error 0.9	2.9 pg/mL Standard Error 1.3	5 pg/mL Standard Error 2.7	5.4 pg/mL Standard Error 1	7.7 pg/mL Standard Error 2	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Tumor Necrosis Factor ἁ - 12 hours on Day 11	NA pg/mL Standard Error NA tests not performed	NA pg/mL Standard Error NA tests not performed	NA pg/mL Standard Error NA tests not performed	NA pg/mL Standard Error NA tests not performed	NA pg/mL Standard Error NA tests not performed	NA pg/mL Standard Error NA tests not performed	—	—	—
Inflammatory Cytokines Tumor Necrosis Factor ἁ - 24 hours on Day 12	2.3 pg/mL Standard Error 0.6	2.8 pg/mL Standard Error 1	15.4 pg/mL Standard Error 20	3.5 pg/mL Standard Error 0.7	5 pg/mL Standard Error 1.4	NA pg/mL Standard Error NA tests not performed	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Date treatment consent signed to date off study, approximately 18 months (m)/27 days(d), 3 m, 9 m/13d, 15 m/20d, 28 m/17d, 1 m/23d, 15 m/8d, 4 m/5d, and 6 m/30d for levels 1-9 respectively.

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	All Participants n=4 Participants All participants on the following dose levels: Level 1 - 0.1 mcg/kg/day x 10 Days Level 2 - 0.25 mcg/kg/day x 10 Days Level 3 - 0.5 mcg/kg/day x 10 Days Level 4 - 1 mcg/kg/day x 10 Days Level 5 - 2 mcg/kg/day x 10 Days Level 6 - 4 mcg/kg/day x 10 Days	Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days n=3 Participants Level 2 - 0.25 mcg/kg/day x 10 Days	Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days n=3 Participants Level 3 - 0.5 mcg/kg/day x 10 Days	Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days n=6 Participants Level 4 - 1 mcg/kg/day x 10 Days	Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days n=9 Participants Level 5 - 2 mcg/kg/day x 10 Days	Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days n=2 Participants Level 6 - 4 mcg/kg/day x 10 Days	Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days n=4 Participants Level 7 - 3 mcg/kg/day x 5 Days	Dose Escalation Level 8 - 4 mcg/kg/Day x 5 Days n=3 Participants Level 8 - 4 mcg/kg/day x 5 Days	Dose Escalation Level 9 - 5 mcg/kg/Day x 5 Days n=4 Participants Level 9 - 5 mcg/kg/day x 5 Days
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)	4 Participants	3 Participants	3 Participants	6 Participants	9 Participants	2 Participants	4 Participants	3 Participants	4 Participants

Adverse Events

Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days

Serious events: 3 serious events

Other events: 6 other events

Deaths: 1 deaths

Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days

Serious events: 2 serious events

Other events: 2 other events

Deaths: 1 deaths

Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Dose Escalation Level 8 - 4 mcg/kg/Day x 5 Days

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Dose Escalation Level 9 - 5 mcg/kg/Day x 5 Days

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days n=4 participants at risk Level 1 - 0.1 mcg/kg/day x 10 Days	Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days n=3 participants at risk Level 2 - 0.25 mcg/kg/day x 10 Days	Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days n=3 participants at risk Level 3 - 0.5 mcg/kg/day x 10 Days	Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days n=6 participants at risk Level 4 - 1 mcg/kg/day x 10 Days	Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days n=9 participants at risk Level 5 - 2 mcg/kg/day x 10 Days	Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days n=2 participants at risk Level 6 - 4 mcg/kg/day x 10 Days	Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days n=4 participants at risk Level 7 - 3 mcg/kg/day x 5 Days	Dose Escalation Level 8 - 4 mcg/kg/Day x 5 Days n=3 participants at risk Level 8 - 4 mcg/kg/day x 5 Days	Dose Escalation Level 9 - 5 mcg/kg/Day x 5 Days n=4 participants at risk Level 9 - 5 mcg/kg/day x 5 Days
Cardiac disorders Atrial fibrillation	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Gastrointestinal disorders Abdominal pain	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Investigations Alanine aminotransferase increased	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Blood and lymphatic system disorders Anemia	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Investigations Aspartate aminotransferase increased	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Vascular disorders Capillary leak syndrome	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Gastrointestinal disorders Diarrhea	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Gastrointestinal disorders Duodenal hemorrhage	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Respiratory, thoracic and mediastinal disorders Dyspnea	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
General disorders Edema face	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
General disorders Fatigue	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
General disorders Fever	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Gastrointestinal disorders Gastritis	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Vascular disorders Hypotension	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Infections and infestations Infections and infestations - Other, Recurrent retropharyngeal infection/abscess	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Investigations Investigations - Other, Direct bilirubin	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
General disorders Multi-organ failure	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Nervous system disorders Nervous system disorders - Other, Cord compression	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Eye disorders Papilledema	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
General disorders Sudden death NOS	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Musculoskeletal and connective tissue disorders Trismus	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Cardiac disorders Ventricular tachycardia	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Vascular disorders Visceral arterial ischemia	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.

Other adverse events

Other adverse events
Measure	Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days n=4 participants at risk Level 1 - 0.1 mcg/kg/day x 10 Days	Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days n=3 participants at risk Level 2 - 0.25 mcg/kg/day x 10 Days	Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days n=3 participants at risk Level 3 - 0.5 mcg/kg/day x 10 Days	Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days n=6 participants at risk Level 4 - 1 mcg/kg/day x 10 Days	Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days n=9 participants at risk Level 5 - 2 mcg/kg/day x 10 Days	Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days n=2 participants at risk Level 6 - 4 mcg/kg/day x 10 Days	Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days n=4 participants at risk Level 7 - 3 mcg/kg/day x 5 Days	Dose Escalation Level 8 - 4 mcg/kg/Day x 5 Days n=3 participants at risk Level 8 - 4 mcg/kg/day x 5 Days	Dose Escalation Level 9 - 5 mcg/kg/Day x 5 Days n=4 participants at risk Level 9 - 5 mcg/kg/day x 5 Days
Gastrointestinal disorders Abdominal distension	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Gastrointestinal disorders Abdominal pain	25.0% 1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	55.6% 5/9 • Number of events 5 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Investigations Activated partial thromboplastin time prolonged	25.0% 1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Renal and urinary disorders Acute kidney injury	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Psychiatric disorders Agitation	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Investigations Alanine aminotransferase increased	25.0% 1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	83.3% 5/6 • Number of events 26 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	77.8% 7/9 • Number of events 12 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 2/4 • Number of events 5 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 3/3 • Number of events 8 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 4/4 • Number of events 7 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Investigations Alkaline phosphatase increased	25.0% 1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 2/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 3/6 • Number of events 14 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 9/9 • Number of events 17 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 2/2 • Number of events 5 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 3/3 • Number of events 12 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 4/4 • Number of events 6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Blood and lymphatic system disorders Anemia	75.0% 3/4 • Number of events 10 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 2/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 2/3 • Number of events 13 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 6/6 • Number of events 37 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 9/9 • Number of events 56 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 2/4 • Number of events 14 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 3/3 • Number of events 9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	75.0% 3/4 • Number of events 7 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Metabolism and nutrition disorders Anorexia	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Psychiatric disorders Anxiety	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Gastrointestinal disorders Ascites	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Investigations Aspartate aminotransferase increased	25.0% 1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	83.3% 5/6 • Number of events 29 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	77.8% 7/9 • Number of events 16 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 2/2 • Number of events 4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 2/4 • Number of events 9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 3/3 • Number of events 6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 4/4 • Number of events 8 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Infections and infestations Bladder infection	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Gastrointestinal disorders Bloating	25.0% 1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	44.4% 4/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Investigations Blood bilirubin increased	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 7 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	22.2% 2/9 • Number of events 7 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 2/2 • Number of events 6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 2/4 • Number of events 5 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 2/3 • Number of events 6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 2/4 • Number of events 4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Eye disorders Blurred vision	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Reproductive system and breast disorders Breast pain	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Injury, poisoning and procedural complications Bruising	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Vascular disorders Capillary leak syndrome	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Infections and infestations Catheter related infection	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Gastrointestinal disorders Cheilitis	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
General disorders Chills	50.0% 2/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 2/6 • Number of events 4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	55.6% 5/9 • Number of events 6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 2/4 • Number of events 8 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	75.0% 3/4 • Number of events 4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Nervous system disorders Cognitive disturbance	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Psychiatric disorders Confusion	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Gastrointestinal disorders Constipation	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	44.4% 4/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	75.0% 3/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	44.4% 4/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Investigations Creatinine increased	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 4/6 • Number of events 11 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	22.2% 2/9 • Number of events 7 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 2/3 • Number of events 8 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 4/4 • Number of events 6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Metabolism and nutrition disorders Dehydration	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Gastrointestinal disorders Diarrhea	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 2/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 3/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 2/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Nervous system disorders Dizziness	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Gastrointestinal disorders Dry mouth	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Skin and subcutaneous tissue disorders Dry skin	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 3/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Nervous system disorders Dysgeusia	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Gastrointestinal disorders Dyspepsia	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Respiratory, thoracic and mediastinal disorders Dyspnea	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	22.2% 2/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
General disorders Edema face	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 3/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
General disorders Edema limbs	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 3/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	44.4% 4/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Nervous system disorders Encephalopathy	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
General disorders Fatigue	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	55.6% 5/9 • Number of events 5 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	75.0% 3/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
General disorders Fever	50.0% 2/4 • Number of events 4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 2/3 • Number of events 6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	83.3% 5/6 • Number of events 12 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	88.9% 8/9 • Number of events 20 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 4/4 • Number of events 14 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 3/3 • Number of events 6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 4/4 • Number of events 10 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Vascular disorders Flushing	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 3/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Gastrointestinal disorders Gastric hemorrhage	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Gastrointestinal disorders Gastrointestinal disorders - Other, Mouth sores	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Gastrointestinal disorders Gastrointestinal disorders - Other, Oral ulcer	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Gastrointestinal disorders Gastrointestinal disorders - Other, angular cheilitis	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Gastrointestinal disorders Gastroparesis	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
General disorders General disorders and administration site conditions - Other, Apthous ulcer	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Nervous system disorders Headache	25.0% 1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 3/6 • Number of events 6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 3/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Renal and urinary disorders Hematuria	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Renal and urinary disorders Hemoglobinuria	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Gastrointestinal disorders Hemorrhoids	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Vascular disorders Hot flashes	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	22.2% 2/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 2/4 • Number of events 4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 3/6 • Number of events 6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Metabolism and nutrition disorders Hypermagnesemia	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Metabolism and nutrition disorders Hypernatremia	25.0% 1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 2/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Vascular disorders Hypertension	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Metabolism and nutrition disorders Hypoalbuminemia	50.0% 2/4 • Number of events 9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 2/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 2/3 • Number of events 7 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 6/6 • Number of events 59 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 9/9 • Number of events 50 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 2/2 • Number of events 5 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 2/4 • Number of events 14 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 3/3 • Number of events 18 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 4/4 • Number of events 14 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Metabolism and nutrition disorders Hypocalcemia	25.0% 1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 4/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 3/9 • Number of events 5 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 4/4 • Number of events 5 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 2/3 • Number of events 7 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 3/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	55.6% 5/9 • Number of events 9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 4/4 • Number of events 6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 4/4 • Number of events 10 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Metabolism and nutrition disorders Hypomagnesemia	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 2/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	22.2% 2/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 4/4 • Number of events 5 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 2/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 4/6 • Number of events 10 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 3/9 • Number of events 15 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 3/3 • Number of events 6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	75.0% 3/4 • Number of events 7 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 2/6 • Number of events 6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	44.4% 4/9 • Number of events 10 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 2/2 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 4/4 • Number of events 7 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 3/3 • Number of events 6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	75.0% 3/4 • Number of events 10 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Vascular disorders Hypotension	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 3/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Infections and infestations Infections and infestations - Other, Cold-like symptoms	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
General disorders Infusion site extravasation	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Psychiatric disorders Insomnia	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Investigations Investigations - Other, Direct bilirubin	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Nervous system disorders Lethargy	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Infections and infestations Lip infection	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Infections and infestations Lung infection	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Investigations Lymphocyte count decreased	100.0% 4/4 • Number of events 18 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 3/3 • Number of events 7 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 3/3 • Number of events 23 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 6/6 • Number of events 48 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 9/9 • Number of events 46 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 2/2 • Number of events 7 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 2/4 • Number of events 17 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 3/3 • Number of events 20 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 4/4 • Number of events 17 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Investigations Lymphocyte count increased	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 6/6 • Number of events 12 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	88.9% 8/9 • Number of events 14 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 3/3 • Number of events 7 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	75.0% 3/4 • Number of events 6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
General disorders Malaise	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Gastrointestinal disorders Mucositis oral	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Skin and subcutaneous tissue disorders Nail ridging	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Gastrointestinal disorders Nausea	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	77.8% 7/9 • Number of events 9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 2/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	75.0% 3/4 • Number of events 4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Investigations Neutrophil count decreased	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 2/6 • Number of events 4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 6/9 • Number of events 21 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 2/3 • Number of events 6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Musculoskeletal and connective tissue disorders Non-cardiac chest pain	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Gastrointestinal disorders Oral dysesthesia	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Gastrointestinal disorders Oral pain	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	22.2% 2/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
General disorders Pain	50.0% 2/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Reproductive system and breast disorders Pelvic pain	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Cardiac disorders Pericardial effusion	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Skin and subcutaneous tissue disorders Periorbital edema	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Vascular disorders Phlebitis	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Investigations Platelet count decreased	25.0% 1/4 • Number of events 4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 2/3 • Number of events 9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 2/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 3/6 • Number of events 10 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	77.8% 7/9 • Number of events 16 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 2/2 • Number of events 4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 2/4 • Number of events 8 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 3/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	75.0% 3/4 • Number of events 6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Renal and urinary disorders Proteinuria	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Skin and subcutaneous tissue disorders Pruritus	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Skin and subcutaneous tissue disorders Rash maculo-papular	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	44.4% 4/9 • Number of events 7 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 2/4 • Number of events 4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 2/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Gastrointestinal disorders Rectal pain	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Psychiatric disorders Restlessness	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Cardiac disorders Sinus tachycardia	50.0% 2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Desquamation	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Erythema, bilateral cheeks	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Facial erythema	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Hands and Feet, Skin Sloughing	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Skin Peeling	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, erythema to cheeks	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Infections and infestations Skin infection	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Nervous system disorders Somnolence	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Respiratory, thoracic and mediastinal disorders Sore throat	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	22.2% 2/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Vascular disorders Superficial thrombophlebitis	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Skin and subcutaneous tissue disorders Telangiectasia	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Musculoskeletal and connective tissue disorders Trismus	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Infections and infestations Upper respiratory infection	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Infections and infestations Urinary tract infection	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Investigations Urine output decreased	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Gastrointestinal disorders Vomiting	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 3/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 2/4 • Number of events 4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.
Investigations White blood cell decreased	25.0% 1/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 2/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	100.0% 3/3 • Number of events 11 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	33.3% 2/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 6/9 • Number of events 23 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	50.0% 2/4 • Number of events 14 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	66.7% 2/3 • Number of events 16 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.	75.0% 3/4 • Number of events 6 • Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.

Additional Information

Dr. Kevin C. Conlon

National Cancer Institute

Phone: 240-858-3570

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place