Trial Outcomes & Findings for CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With Nivolumab (NCT NCT03123783)

Last Updated: 2023-12-26

Results Overview

All toxicities were graded according to the NCI-CTCAE version 4.03. DLT was defined as any of the following events attributed to APX005M and nivolumab combination: * Grade 4 hematologic toxicity lasting ≥ 7 days (except asymptomatic lymphopenia) * Grade 3 or 4 neutropenia with a single temperature of \>38.3◦ C (101◦ F) or a sustained temperature of ≥38◦ C (100.4◦ F) for more than one hour * Grade 4 thrombocytopenia or Grade ≥3 thrombocytopenia with signs or symptoms of bleeding or requiring platelet transfusion * Grade 4 non-hematologic toxicity * Grade 3 non-hematologic toxicity lasting \>3 days despite optimal supportive care * Any Grade ≥ 3 non-hematologic laboratory value if: medical intervention is required to treat the subject, abnormality leads to hospitalization, or abnormality persists for \>1 week * Failure to recover from a treatment-related AE to baseline or ≤ Grade 1 within 12 weeks of last dose of investigational product * Grade 5 toxicity.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

140 participants

Primary outcome timeframe

Up to 21 days following first dose of APX005M and nivolumab

Results posted on

2023-12-26

Participant Flow

In Phase 1b dose-escalation portion of the study, a total of 10 participants were enrolled at 3 dose levels. Nine participants received at least one dose of both study drugs. 0.3 mg/kg was determined as the recommended phase 2 (RP2D) dose. Note: The 3 participants treated in DL3 of Phase 1b are at the RP2D and are also included in Phase 2 results. One participant was rolled over to Cohort 1 (Phase 2) and 2 participants were rolled over into Cohort 2 (Phase 2) to continue treatment.

For the phase 2 cohorts 1,2,3A,3B, a total of 133 participants were enrolled in 4 cohorts to receive APX005M at 0.3 mg/kg (RP2D) plus nivolumab at 360 mg IV. Three subjects who were treated at the RP2D in the Phase 1b dose-escalation portion of the study were included in Phase 2 of the relevant disease-specific cohort. The study enrollment was completed as planned and all primary and secondary outcome measures and adverse events were collected even though the study was ended by the sponsor.

Participant milestones

Participant milestones
Measure	DL1 - APX005M 0.03 mg/kg + Nivolumab (Phase 1b) Participants received 0.03mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg	DL2 - APX005M 0.1 mg/kg + Nivolumab (Phase 1b) Participants received 0.1mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg	DL3 - APX005M 0.3 mg/kg + Nivolumab (Phase 1b) Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg	Cohort 1(Arm)/ inNSCLC (Phase 2) Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Cohort 2(Arm)/ PD1-MM (Phase 2) - Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Cohort 3A(Arm)/ PD1-NSCLC (Phase 2) Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Cohort 3B(Arm)/ PD1-NSCLC (Phase 2) Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV
Phase 1b STARTED	3	4	3	0	0	0	0
Phase 1b Participants in the Safety Population	3	3	3	0	0	0	0
Phase 1b Participants in the Efficacy Population	3	3	3	0	0	0	0
Phase 1b COMPLETED	3	3	0	0	0	0	0
Phase 1b NOT COMPLETED	0	1	3	0	0	0	0
Phase 2 STARTED	0	0	0	53	38	14	28
Phase 2 Phase 2 Participants in Safety Population	0	0	0	53	38	14	28
Phase 2 Phase 2 Participants in the Efficacy (EE) Population	0	0	0	48	33	12	25
Phase 2 COMPLETED	0	0	0	48	33	12	25
Phase 2 NOT COMPLETED	0	0	0	5	5	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	DL2 - APX005M 0.1 mg/kg + Nivolumab (Phase 1b) Participants received 0.1mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg	DL3 - APX005M 0.3 mg/kg + Nivolumab (Phase 1b) Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg	Cohort 1(Arm)/ inNSCLC (Phase 2) Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Cohort 2(Arm)/ PD1-MM (Phase 2) - Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Cohort 3A(Arm)/ PD1-NSCLC (Phase 2) Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Cohort 3B(Arm)/ PD1-NSCLC (Phase 2) Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV
Phase 1b Removed from treatment prior to APX005M administration	1	0	0	0	0	0
Phase 1b Participants rolled over to Phase 2	0	3	0	0	0	0
Phase 2 No post baseline tumor assesment on treatment period	0	0	5	2	2	3
Phase 2 Prior systemic therapy not allowed (1 patient did not complete post baseline tumor assessment)	0	0	0	3	0	0

Baseline Characteristics

The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DL1 - APX005M 0.03 mg/kg + Nivolumab (Phase 1b) n=3 Participants Participants received 0.03 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	DL2 - APX005M 0.1 mg/kg + Nivolumab (Phase 1b) n=4 Participants Participants received 0.1 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	DL3 - APX005M 0.3 mg/kg + Nivolumab (Phase 1b) n=3 Participants Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Cohort 1(Arm)/ inNSCLC (Phase 2) n=52 Participants Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Cohort 2(Arm)/ PD1-MM (Phase 2) n=36 Participants Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Cohort 3A(Arm)/ PD1-NSCLC (Phase 2) n=14 Participants Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Cohort 3B(Arm)/ PD1-NSCLC (Phase 2) n=28 Participants Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Total n=140 Participants Total of all reporting groups
Age, Categorical Phase 1b Age, Categorical · <=18 years	0 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	0 Participants n=4 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	0 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	0 Participants n=10 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.
Age, Categorical Phase 1b Age, Categorical · Between 18 and 65 years	1 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	3 Participants n=4 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	2 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	6 Participants n=10 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.
Age, Categorical Phase 1b Age, Categorical · >=65 years	2 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	1 Participants n=4 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	1 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	4 Participants n=10 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.
Age, Categorical Phase 2 Age, Categorical · <=18 years	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	0 Participants n=52 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	0 Participants n=36 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	0 Participants n=14 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	0 Participants n=28 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	0 Participants n=130 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.
Age, Categorical Phase 2 Age, Categorical · Between 18 and 65 years	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	17 Participants n=52 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	19 Participants n=36 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	5 Participants n=14 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	15 Participants n=28 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	56 Participants n=130 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.
Age, Categorical Phase 2 Age, Categorical · >=65 years	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	35 Participants n=52 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	17 Participants n=36 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	9 Participants n=14 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	13 Participants n=28 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.	74 Participants n=130 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned.
Sex: Female, Male Phase 1b · Female	0 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	1 Participants n=4 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	1 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	2 Participants n=10 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned
Sex: Female, Male Phase 1b · Male	3 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	3 Participants n=4 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	2 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	8 Participants n=10 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned
Sex: Female, Male Phase 2 · Female	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	21 Participants n=52 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	15 Participants n=36 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	5 Participants n=14 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	9 Participants n=28 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	50 Participants n=130 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned
Sex: Female, Male Phase 2 · Male	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	31 Participants n=52 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	21 Participants n=36 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	9 Participants n=14 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	19 Participants n=28 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	80 Participants n=130 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned
Ethnicity (NIH/OMB) Phase 1b · Hispanic or Latino	0 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=4 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=10 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned
Ethnicity (NIH/OMB) Phase 1b · Not Hispanic or Latino	3 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	4 Participants n=4 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	3 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	10 Participants n=10 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned
Ethnicity (NIH/OMB) Phase 1b · Unknown or Not Reported	0 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=4 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=10 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned
Ethnicity (NIH/OMB) Phase 2 · Hispanic or Latino	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	10 Participants n=52 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	4 Participants n=36 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	3 Participants n=14 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	4 Participants n=28 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	21 Participants n=130 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned
Ethnicity (NIH/OMB) Phase 2 · Not Hispanic or Latino	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	42 Participants n=52 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	32 Participants n=36 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	11 Participants n=14 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	24 Participants n=28 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	109 Participants n=130 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned
Ethnicity (NIH/OMB) Phase 2 · Unknown or Not Reported	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=52 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=36 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=14 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=28 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=130 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned
Race (NIH/OMB) Phase 1b · American Indian or Alaska Native	0 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=4 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=10 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned
Race (NIH/OMB) Phase 1b · Asian	0 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=4 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=10 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned
Race (NIH/OMB) Phase 1b · Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=4 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=10 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned
Race (NIH/OMB) Phase 1b · Black or African American	0 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	1 Participants n=4 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	1 Participants n=10 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned
Race (NIH/OMB) Phase 1b · White	3 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	3 Participants n=4 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	3 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	9 Participants n=10 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned
Race (NIH/OMB) Phase 1b · More than one race	0 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=4 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=10 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned
Race (NIH/OMB) Phase 1b · Unknown or Not Reported	0 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=4 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=10 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned
Race (NIH/OMB) Phase 2 · American Indian or Alaska Native	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=52 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	1 Participants n=36 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=14 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=28 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	1 Participants n=130 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned
Race (NIH/OMB) Phase 2 · Asian	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	1 Participants n=52 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=36 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=14 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=28 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	1 Participants n=130 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned
Race (NIH/OMB) Phase 2 · Native Hawaiian or Other Pacific Islander	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=52 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=36 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=14 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=28 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=130 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned
Race (NIH/OMB) Phase 2 · Black or African American	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	3 Participants n=52 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=36 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=14 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	1 Participants n=28 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	4 Participants n=130 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned
Race (NIH/OMB) Phase 2 · White	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	48 Participants n=52 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	35 Participants n=36 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	14 Participants n=14 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	27 Participants n=28 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	124 Participants n=130 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned
Race (NIH/OMB) Phase 2 · More than one race	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=52 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=36 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=14 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=28 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=130 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned
Race (NIH/OMB) Phase 2 · Unknown or Not Reported	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=52 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=36 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=14 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=28 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=130 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned
Region of Enrollment United States	3 participants n=3 Participants	4 participants n=4 Participants	3 participants n=3 Participants	34 participants n=52 Participants	20 participants n=36 Participants	6 participants n=14 Participants	6 participants n=28 Participants	76 participants n=140 Participants
Region of Enrollment Spain	0 participants n=3 Participants	0 participants n=4 Participants	0 participants n=3 Participants	18 participants n=52 Participants	16 participants n=36 Participants	8 participants n=14 Participants	22 participants n=28 Participants	64 participants n=140 Participants
Weight Phase 1b	85.3 kg n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	84.33 kg n=4 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	104.3 kg n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	—	—	—	—	90.63 kg n=10 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned
Weight Phase 2	—	—	—	76.53 kg n=52 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	80.15 kg n=36 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	74.42 kg n=14 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	71.80 kg n=28 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	76.29 kg n=130 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned
ECOG Performance Status Phase 1b · ECOG Score 0	1 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	1 Participants n=4 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	3 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	—	—	—	—	5 Participants n=10 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned
ECOG Performance Status Phase 1b · ECOG Score 1	2 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	3 Participants n=4 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants n=3 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	—	—	—	—	5 Participants n=10 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned
ECOG Performance Status Phase 2 · ECOG Score 0	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	13 Participants n=52 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	28 Participants n=36 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	7 Participants n=14 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	8 Participants n=28 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	56 Participants n=130 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned
ECOG Performance Status Phase 2 · ECOG Score 1	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	0 Participants The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	39 Participants n=52 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	8 Participants n=36 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	7 Participants n=14 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	20 Participants n=28 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned	74 Participants n=130 Participants • The participants were enrolled into multiple Arms/Groups and are reported in the Arm/Group they were originally assigned

PRIMARY outcome

Timeframe: Up to 21 days following first dose of APX005M and nivolumab

Population: All participants in the safety population who received at least 1 dose of study drug in the escalation cohorts (APX005M 0.03 mg/kg + nivolumab; APX005M 0.1 mg/kg + nivolumab; APX005M 0.3 mg/kg + nivolumab)

Outcome measures

Outcome measures
Measure	Phase 1b Escalation n=9 Participants Participants received intravenous infusions of APX005M starting at DL 0.03, .1 or .3 mg/kg administered every 21 days in combination with nivolumab 360 mg IV	Cohort 2(Arm)/PD1-MM (Phase 2) Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Cohort 3A(Arm)/PD1-NSCLC (Phase 2) Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Cohort 3B(Arm)/PD1-NSCLC (Phase 2) Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV
Number of Participants Experiencing Dose-limiting Toxicities (DLTs)	0 Participants	—	—	—

PRIMARY outcome

Timeframe: Up to 21 days following first dose of APX005M and nivolumab

Establish the MTD dose of APX005M combined with 360 mg of nivolumab for which for which \< 33% of DLT- evaluable participants experience a DLT. In Phase 1b, the RP2D was based on the overall safety and tolerability of the combination of APX005M and nivolumab by testing increasing doses up to 0.3 mg/kg APX005M + nivolumab.

Outcome measures

Outcome measures
Measure	Phase 1b Escalation n=9 Participants Participants received intravenous infusions of APX005M starting at DL 0.03, .1 or .3 mg/kg administered every 21 days in combination with nivolumab 360 mg IV	Cohort 2(Arm)/PD1-MM (Phase 2) Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Cohort 3A(Arm)/PD1-NSCLC (Phase 2) Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Cohort 3B(Arm)/PD1-NSCLC (Phase 2) Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV
Maximum Tolerated Dose (MTD) of APX005M + Nivolumab (Phase 1b)	NA mg/kg The MTD was formally not reached.	—	—	—

PRIMARY outcome

Timeframe: From start of the treatment (Day 1) until disease progression, withdrawal of consent, death, initiation of any anticancer therapy, lost to follow-up, or termination by the Sponsor, whichever comes first (for Phase 2: maximum up to 27 months)

Population: Cohort 1: immunotherapy naïve metastatic or locally advanced NSCLC, Cohort 2: unresectable or metastatic melanoma that progressed during treatment with anti-PD-1/PD-L1 therapy and had confirmation of PD ≥4 weeks, Cohort 3: PD1-NSCLC metastatic or locally advanced NSCLC not amenable to curative treatment that progressed during prior treatment with anti-PD-1/PD-L1 therapy. Cohort 3A: best response of PD or with SD \<16 weeks, Cohort 3B includes PD1-NSCLC with tumor response or with SD ≥ 16 weeks

ORR defined as the rate of patients who show as best overall response; either a complete response (CR) or a partial response (PR). The ORR can be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. using computed tomography (CT) scans/magnetic resonance imaging (MRI). Per RECIST v1.1, for target lesions and assessed by imaging: Complete Response, (CR), Disappearance of all target lesions and nontarget (NT) lesions; Partial Response (PR), \>30% decrease in the sum of the longest diameter of target lesions and no PD in NT lesions or new lesions; Objective Response Rate (ORR)=CR + PR.

Outcome measures

Outcome measures
Measure	Phase 1b Escalation n=48 Participants Participants received intravenous infusions of APX005M starting at DL 0.03, .1 or .3 mg/kg administered every 21 days in combination with nivolumab 360 mg IV	Cohort 2(Arm)/PD1-MM (Phase 2) n=33 Participants Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Cohort 3A(Arm)/PD1-NSCLC (Phase 2) n=12 Participants Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Cohort 3B(Arm)/PD1-NSCLC (Phase 2) n=25 Participants Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV
Phase 2 Evaluate the Objective Response Rate (ORR) by RECIST 1.1 and iRECIST in Each Cohort / Group	16.67 Percentage of participants Interval 8.57 to 28.07	15.15 Percentage of participants Interval 6.17 to 29.25	0.00 Percentage of participants Interval 0.0 to 22.09	0.00 Percentage of participants Interval 0.0 to 11.29

SECONDARY outcome

Timeframe: Day 1 up to 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) following the after the last dose of APX005M and/or nivolumab (from start of treatment up to 27 months)

Population: Any Adverse Event a participant has with two or more events in that category is counted only once

Number of participants with TEAEs are reported.

Outcome measures

Outcome measures
Measure	Phase 1b Escalation n=53 Participants Participants received intravenous infusions of APX005M starting at DL 0.03, .1 or .3 mg/kg administered every 21 days in combination with nivolumab 360 mg IV	Cohort 2(Arm)/PD1-MM (Phase 2) n=38 Participants Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Cohort 3A(Arm)/PD1-NSCLC (Phase 2) n=14 Participants Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Cohort 3B(Arm)/PD1-NSCLC (Phase 2) n=28 Participants Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV
Safety of the APX005M and Nivolumab Combination (Phase 2)	52 Participants	36 Participants	14 Participants	28 Participants

SECONDARY outcome

Timeframe: Maximum up to 25 months

Duration of Response is defined as the time from the first evidence of confirmed partial response (PR) or better by Per RECIST v1.1 to disease progression or death due to any cause; in subjects alive without progressive disease (PD), DOR was censored on the date of the last tumor assessment. PD is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Phase 1b Escalation n=8 Participants Participants received intravenous infusions of APX005M starting at DL 0.03, .1 or .3 mg/kg administered every 21 days in combination with nivolumab 360 mg IV	Cohort 2(Arm)/PD1-MM (Phase 2) n=5 Participants Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Cohort 3A(Arm)/PD1-NSCLC (Phase 2) Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Cohort 3B(Arm)/PD1-NSCLC (Phase 2) Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV
Duration of Response (DOR) as Per RECIST 1.1(Phase 2)	NA Months Interval 3.9 to 21.4 NA because median duration of response not reached.	NA Months Interval 4.2 to 24.7 NA because median duration of response not reached. 4/5 participants had ongoing responses at the time of study closure.	—	—

SECONDARY outcome

Timeframe: From start of treatment (Day 1) up to 27 months

Progression-free Survival (PFS) in each cohort, measured from first dose to the earlier of PD (by RECIST 1.1) or death due to any cause, whichever occurs first.

Outcome measures

Outcome measures
Measure	Phase 1b Escalation n=48 Participants Participants received intravenous infusions of APX005M starting at DL 0.03, .1 or .3 mg/kg administered every 21 days in combination with nivolumab 360 mg IV	Cohort 2(Arm)/PD1-MM (Phase 2) n=33 Participants Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Cohort 3A(Arm)/PD1-NSCLC (Phase 2) n=12 Participants Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Cohort 3B(Arm)/PD1-NSCLC (Phase 2) n=25 Participants Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV
Median Progression-free Survival (PFS) (Phase 2)	4.11 Months Interval 3.45 to 5.52	1.97 Months Interval 1.87 to 3.61	3.43 Months Interval 2.0 to 3.88	3.65 Months Interval 1.84 to 3.81

SECONDARY outcome

Timeframe: * Outcome Measure Time Frame From start of treatment (Day 1) to 6 months

PFS rate in each cohort, measured from first dose to the earlier of PD (by RECIST 1.1) or death due to any cause, whichever occurs first.

Outcome measures

Outcome measures
Measure	Phase 1b Escalation n=48 Participants Participants received intravenous infusions of APX005M starting at DL 0.03, .1 or .3 mg/kg administered every 21 days in combination with nivolumab 360 mg IV	Cohort 2(Arm)/PD1-MM (Phase 2) n=33 Participants Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Cohort 3A(Arm)/PD1-NSCLC (Phase 2) n=12 Participants Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Cohort 3B(Arm)/PD1-NSCLC (Phase 2) n=25 Participants Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV
6-month PFS Rate (Phase 2)	33.10 Percentage of participants Interval 20.1 to 46.68	21.21 Percentage of participants Interval 9.35 to 36.25	25.00 Percentage of participants Interval 6.01 to 50.48	12.92 Percentage of participants Interval 3.27 to 29.41

Adverse Events

DL1 - APX005M 0.03 mg/kg + Nivolumab (Phase 1b Escalation)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

DL2 - APX005M 0.1 mg/kg + Nivolumab (Phase 1b Escalation)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

DL3 - APX005M 0.3 mg/kg + Nivolumab (Phase 1b Escalation)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 1(Arm)/ inNSCLC (Phase 2) - Includes Data From 1 Participant From DL3

Serious events: 25 serious events

Other events: 52 other events

Deaths: 18 deaths

Cohort 2(Arm)/ PD1-MM (Phase 2) - Includes Data From 2 Participants From DL3

Serious events: 6 serious events

Other events: 36 other events

Deaths: 4 deaths

Cohort 3A(Arm)/ PD1-NSCLC (Phase 2)

Serious events: 6 serious events

Other events: 14 other events

Deaths: 4 deaths

Cohort 3B(Arm)/ PD1-NSCLC (Phase 2)

Serious events: 13 serious events

Other events: 28 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	DL1 - APX005M 0.03 mg/kg + Nivolumab (Phase 1b Escalation) n=3 participants at risk Participants received 0.03 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	DL2 - APX005M 0.1 mg/kg + Nivolumab (Phase 1b Escalation) n=3 participants at risk Participants received 0.1 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	DL3 - APX005M 0.3 mg/kg + Nivolumab (Phase 1b Escalation) n=3 participants at risk Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV Note: One participant was rolled over to Cohort 1 (Phase 2) and 2 participants were rolled over into Cohort 2 (Phase 2).	Cohort 1(Arm)/ inNSCLC (Phase 2) - Includes Data From 1 Participant From DL3 n=53 participants at risk Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Cohort 2(Arm)/ PD1-MM (Phase 2) - Includes Data From 2 Participants From DL3 n=38 participants at risk Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Cohort 3A(Arm)/ PD1-NSCLC (Phase 2) n=14 participants at risk Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Cohort 3B(Arm)/ PD1-NSCLC (Phase 2) n=28 participants at risk Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV
Cardiac disorders Acute coronary syndrome	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.8% 2/53 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Cardiac disorders Acute myocardial infarction	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Cardiac disorders Cardiac arrest	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Cardiac disorders Cardio-respiratory arrest	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Cardiac disorders Pericardial effusion	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Gastrointestinal disorders Constipation	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Gastrointestinal disorders Gastritis	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Gastrointestinal disorders Intestinal obstruction	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Gastrointestinal disorders Pancreatitis	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Gastrointestinal disorders Pancreatitis acute	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
General disorders Facial pain	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
General disorders General physical health deterioration	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
General disorders Pain	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
General disorders Pyrexia	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Immune system disorders Cytokine release syndrome	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 2/28 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Infections and infestations Appendicitis	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Infections and infestations Bacteraemia	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Infections and infestations Bronchitis	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Infections and infestations Infuenza	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Infections and infestations Lung abscess	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Infections and infestations Lung infection	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Infections and infestations Pneumonia	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.5% 4/53 • Number of events 5 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	14.3% 2/14 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 2/28 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Infections and infestations Sepsis	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Infections and infestations Streptococcal bacteraemia	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Injury, poisoning and procedural complications Fall	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Injury, poisoning and procedural complications Femur fracture	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Injury, poisoning and procedural complications Hip fracture	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Injury, poisoning and procedural complications Radius fracture	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Investigations Blood bilirubin increased	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Investigations Weight decreased	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone neoplasm	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Nervous system disorders Brain oedema	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Nervous system disorders Cerebrovascular accident	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.8% 2/53 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Nervous system disorders Encephalitis autoimmune	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Nervous system disorders Seizure	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.8% 2/53 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Nervous system disorders Syncope	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Psychiatric disorders Confusional state	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.8% 2/53 • Number of events 4 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.8% 2/53 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 2/28 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.8% 2/53 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Respiratory, thoracic and mediastinal disorders Pulmonary artery thrombosis	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.7% 3/53 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 2/28 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Vascular disorders Deep vein thrombosis	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Eye disorders Optic ischaemic neuropathy	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Gastrointestinal disorders Colitis	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.8% 2/53 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect

Other adverse events

Other adverse events
Measure	DL1 - APX005M 0.03 mg/kg + Nivolumab (Phase 1b Escalation) n=3 participants at risk Participants received 0.03 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	DL2 - APX005M 0.1 mg/kg + Nivolumab (Phase 1b Escalation) n=3 participants at risk Participants received 0.1 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	DL3 - APX005M 0.3 mg/kg + Nivolumab (Phase 1b Escalation) n=3 participants at risk Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV Note: One participant was rolled over to Cohort 1 (Phase 2) and 2 participants were rolled over into Cohort 2 (Phase 2).	Cohort 1(Arm)/ inNSCLC (Phase 2) - Includes Data From 1 Participant From DL3 n=53 participants at risk Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Cohort 2(Arm)/ PD1-MM (Phase 2) - Includes Data From 2 Participants From DL3 n=38 participants at risk Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Cohort 3A(Arm)/ PD1-NSCLC (Phase 2) n=14 participants at risk Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV	Cohort 3B(Arm)/ PD1-NSCLC (Phase 2) n=28 participants at risk Participants received 0.3 mg/kg of APX005M administered every 21 days in combination with nivolumab 360 mg IV
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	66.7% 2/3 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	24.5% 13/53 • Number of events 31 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	10.5% 4/38 • Number of events 8 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	21.4% 6/28 • Number of events 10 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Cardiac disorders Palpitations	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.3% 2/38 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Cardiac disorders Sinus tachycardia	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.7% 3/53 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Cardiac disorders Tachycardia	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	13.2% 7/53 • Number of events 7 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.3% 2/38 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 2/28 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Endocrine disorders Hyperthyroidism	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.5% 4/53 • Number of events 4 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Endocrine disorders Hypothyroidism	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	9.4% 5/53 • Number of events 5 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.3% 2/38 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Eye disorders Vision blurred	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.8% 2/53 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.7% 3/53 • Number of events 7 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.3% 2/38 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	14.3% 2/14 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	21.4% 3/14 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	18.9% 10/53 • Number of events 15 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	13.2% 5/38 • Number of events 5 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	21.4% 3/14 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	66.7% 2/3 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	22.6% 12/53 • Number of events 37 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	15.8% 6/38 • Number of events 8 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	14.3% 2/14 • Number of events 8 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 2/28 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Gastrointestinal disorders Dry mouth	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	11.3% 6/53 • Number of events 6 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.3% 2/38 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	14.3% 2/14 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.3% 2/38 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Gastrointestinal disorders Dysphagia	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 2/28 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 7 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	100.0% 3/3 • Number of events 5 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	45.3% 24/53 • Number of events 54 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	47.4% 18/38 • Number of events 22 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	50.0% 7/14 • Number of events 13 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	28.6% 8/28 • Number of events 13 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Gastrointestinal disorders Odynophagia	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 2/28 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Gastrointestinal disorders Stomatitis	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.5% 4/53 • Number of events 5 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	66.7% 2/3 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	100.0% 3/3 • Number of events 4 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	34.0% 18/53 • Number of events 46 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	26.3% 10/38 • Number of events 19 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	14.3% 2/14 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	17.9% 5/28 • Number of events 8 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
General disorders Asthenia	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	13.2% 7/53 • Number of events 8 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	15.8% 6/38 • Number of events 10 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	28.6% 4/14 • Number of events 6 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	42.9% 12/28 • Number of events 17 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
General disorders Chest discomfort	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	14.3% 2/14 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
General disorders Chest pain	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.8% 2/53 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	17.9% 5/28 • Number of events 8 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
General disorders Chills	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	66.7% 2/3 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	100.0% 3/3 • Number of events 5 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	56.6% 30/53 • Number of events 65 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	50.0% 19/38 • Number of events 51 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	35.7% 5/14 • Number of events 14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	46.4% 13/28 • Number of events 24 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
General disorders Fatigue	100.0% 3/3 • Number of events 4 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	66.7% 2/3 • Number of events 8 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	34.0% 18/53 • Number of events 41 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	39.5% 15/38 • Number of events 36 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	35.7% 5/14 • Number of events 12 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	14.3% 4/28 • Number of events 4 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
General disorders Malaise	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.8% 2/53 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	10.5% 4/38 • Number of events 4 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	21.4% 3/14 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
General disorders Non-cardiac chest pain	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	9.4% 5/53 • Number of events 5 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
General disorders Oedema peripheral	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	66.7% 2/3 • Number of events 4 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.5% 4/53 • Number of events 7 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.9% 3/38 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	21.4% 3/14 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 2/28 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
General disorders Pain	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	9.4% 5/53 • Number of events 6 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
General disorders Pyrexia	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	66.7% 2/3 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	66.7% 2/3 • Number of events 4 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	52.8% 28/53 • Number of events 56 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	68.4% 26/38 • Number of events 57 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	50.0% 7/14 • Number of events 34 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	42.9% 12/28 • Number of events 24 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Immune system disorders Cytokine release syndrome	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.7% 3/53 • Number of events 4 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Infections and infestations Nasopharyngitis	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.7% 3/53 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 2/28 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Infections and infestations Pneumonia	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	11.3% 6/53 • Number of events 8 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Infections and infestations Respiratory tract infection	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	14.3% 4/28 • Number of events 4 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Infections and infestations Sinusitis	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 2/28 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.8% 2/53 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	10.5% 4/38 • Number of events 4 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	14.3% 2/14 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Infections and infestations Urinary tract infection	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.8% 2/53 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.3% 2/38 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Injury, poisoning and procedural complications Fall	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.5% 4/53 • Number of events 6 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	9.4% 5/53 • Number of events 6 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.9% 3/38 • Number of events 4 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	14.3% 2/14 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	10.7% 3/28 • Number of events 6 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Investigations Alanine aminotransferase increased	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	20.8% 11/53 • Number of events 33 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	28.9% 11/38 • Number of events 19 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	28.6% 4/14 • Number of events 6 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	28.6% 8/28 • Number of events 34 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Investigations Blood alkaline phosphatase	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	14.3% 2/14 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	17.0% 9/53 • Number of events 34 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	18.4% 7/38 • Number of events 12 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	10.7% 3/28 • Number of events 5 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Investigations Blood bilirubin increased	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.7% 3/53 • Number of events 4 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.9% 3/38 • Number of events 5 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 4 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Investigations Blood creatinine increased	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	9.4% 5/53 • Number of events 8 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 5 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Investigations Blood lactate dehydrogenase increased	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.9% 3/38 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Investigations Gamma-glutamyltransferase increased	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	15.1% 8/53 • Number of events 19 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	18.4% 7/38 • Number of events 18 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	28.6% 4/14 • Number of events 10 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	17.9% 5/28 • Number of events 15 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Investigations Haemoglobin decreased	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 7 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	10.7% 3/28 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Investigations Lipase increased	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	9.4% 5/53 • Number of events 9 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Investigations Platelet count decreased	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.5% 4/53 • Number of events 10 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Investigations Weight decreased	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	26.4% 14/53 • Number of events 21 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	10.7% 3/28 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	66.7% 2/3 • Number of events 9 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	26.4% 14/53 • Number of events 15 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	10.5% 4/38 • Number of events 4 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	28.6% 4/14 • Number of events 5 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	25.0% 7/28 • Number of events 8 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	9.4% 5/53 • Number of events 10 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 2/28 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.5% 4/53 • Number of events 4 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.5% 4/53 • Number of events 4 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 2/28 • Number of events 5 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.7% 3/53 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Metabolism and nutrition disorders Hyponatraemia	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.5% 4/53 • Number of events 6 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 5 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	22.6% 12/53 • Number of events 23 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	15.8% 6/38 • Number of events 16 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	21.4% 3/14 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	17.9% 5/28 • Number of events 6 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Musculoskeletal and connective tissue disorders Back pain	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	15.1% 8/53 • Number of events 11 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	10.5% 4/38 • Number of events 6 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 2/28 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.7% 3/53 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.7% 3/53 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.5% 4/53 • Number of events 4 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.8% 2/53 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.3% 2/38 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Musculoskeletal and connective tissue disorders Musculoskeletal pain	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.8% 2/53 • Number of events 4 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	14.3% 2/14 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 2/28 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.5% 4/53 • Number of events 4 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	15.8% 6/38 • Number of events 10 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.8% 2/53 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 2/28 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.8% 2/53 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.9% 3/38 • Number of events 6 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	17.9% 5/28 • Number of events 5 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Nervous system disorders Dizziness	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.7% 3/53 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.3% 2/38 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Nervous system disorders Dysgeusia	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.7% 3/53 • Number of events 4 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.3% 2/38 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Nervous system disorders Headache	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	15.1% 8/53 • Number of events 13 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	21.1% 8/38 • Number of events 20 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	14.3% 2/14 • Number of events 4 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	14.3% 4/28 • Number of events 4 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Nervous system disorders Somnolence	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	14.3% 2/14 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Psychiatric disorders Anxiety	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	9.4% 5/53 • Number of events 5 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Psychiatric disorders Confusional state	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.7% 3/53 • Number of events 4 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Psychiatric disorders Depression	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.7% 3/53 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Psychiatric disorders Insomnia	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	24.5% 13/53 • Number of events 14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Renal and urinary disorders Chromaturia	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.3% 2/38 • Number of events 7 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Renal and urinary disorders Dysuria	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.3% 2/38 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.7% 3/53 • Number of events 7 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	24.5% 13/53 • Number of events 16 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.9% 3/38 • Number of events 4 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	21.4% 3/14 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	35.7% 10/28 • Number of events 13 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.8% 2/53 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.3% 2/38 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	39.6% 21/53 • Number of events 30 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.9% 3/38 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	42.9% 6/14 • Number of events 8 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	28.6% 8/28 • Number of events 9 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.7% 3/53 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.8% 2/53 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 2/28 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.7% 3/53 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.3% 2/38 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Respiratory, thoracic and mediastinal disorders Pleural effusion	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.5% 4/53 • Number of events 4 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Respiratory, thoracic and mediastinal disorders Pneumonitis	33.3% 1/3 • Number of events 6 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.3% 2/38 • Number of events 4 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	14.3% 2/14 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	9.4% 5/53 • Number of events 6 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.7% 3/53 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	14.3% 2/14 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 2/28 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	100.0% 3/3 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	30.2% 16/53 • Number of events 34 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	34.2% 13/38 • Number of events 15 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	28.6% 4/14 • Number of events 7 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	14.3% 4/28 • Number of events 7 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Skin and subcutaneous tissue disorders Rash	33.3% 1/3 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	66.7% 2/3 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	17.0% 9/53 • Number of events 13 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	26.3% 10/38 • Number of events 13 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.5% 4/53 • Number of events 9 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Vascular disorders Flushing	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	11.3% 6/53 • Number of events 8 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.9% 3/38 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 2/28 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Vascular disorders Hypertension	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	20.8% 11/53 • Number of events 16 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.3% 2/38 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	10.7% 3/28 • Number of events 5 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Vascular disorders Hypotension	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	18.9% 10/53 • Number of events 16 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	10.5% 4/38 • Number of events 5 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	10.7% 3/28 • Number of events 4 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Investigations Amylase increased	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.7% 3/53 • Number of events 5 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.3% 2/38 • Number of events 4 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 2/28 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Investigations Aspartate aminotransferase increased	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 5 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	22.6% 12/53 • Number of events 23 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	23.7% 9/38 • Number of events 16 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	28.6% 4/14 • Number of events 5 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	28.6% 8/28 • Number of events 17 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Cardiac disorders Atrial Fibrillation	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.8% 2/53 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Ear and labyrinth disorders Ear Pain	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.3% 2/38 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Ear and labyrinth disorders Vertigo	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.3% 2/38 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Eye disorders Vitreous floaters	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
General disorders Influenza like illness	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	66.7% 2/3 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.8% 2/53 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Infections and infestations Fungal infection	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Infections and infestations Localised infection	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Infections and infestations Lung infection	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Infections and infestations Skin infection	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Investigations Lymphocyte count decrease	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Investigations Monocyte count decreased	33.3% 1/3 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Musculoskeletal and connective tissue disorders Muscle rigidity	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Nervous system disorders Hypoaesthesia	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Nervous system disorders Presyncope	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Renal and urinary disorders Haematuria	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Renal and urinary disorders Pollakiuria	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Respiratory, thoracic and mediastinal disorders Dyspnoea at rest	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Respiratory, thoracic and mediastinal disorders Hypoxia	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.8% 2/53 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Respiratory, thoracic and mediastinal disorders Lung infiltration	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Respiratory, thoracic and mediastinal disorders Productive cough	33.3% 1/3 • Number of events 4 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.8% 2/53 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.8% 2/53 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Skin and subcutaneous tissue disorders Blister	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	66.7% 2/3 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.8% 2/53 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.3% 2/38 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.8% 2/53 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Skin and subcutaneous tissue disorders Skin hypopigmentation	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Gastrointestinal disorders Toothache	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
General disorders Discomfort	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
General disorders Performance status decreased	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Immune system disorders Hypersensitivity	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Eye disorders Asthenopia	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Eye disorders Dry Eye	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Eye disorders Eye Pain	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Eye disorders Retinal exudates	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Infections and infestations Anorectal infection	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Infections and infestations Candida infection	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.8% 2/53 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Infections and infestations Gingivitis	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Infections and infestations Herpes zoster	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Infections and infestations Pharygitis	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Investigations Blood cortisol decreased	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Investigations Blood glucose increased	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Investigations Blood urea increased	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Musculoskeletal and connective tissue disorders Ostenonecrosis of jaw	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Nervous system disorders Lethargy	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Nervous system disorders Neuralgia	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Nervous system disorders Tremor	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	2.6% 1/38 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	3.6% 1/28 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Nervous system disorders Vocal cord paralysis	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Psychiatric disorders Depressive symptom	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Psychiatric disorders Disorientation	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Skin and subcutaneous tissue disorders Lichenoid keratosis	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Skin and subcutaneous tissue disorders Pruitus generalised	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	5.7% 3/53 • Number of events 3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Blood and lymphatic system disorders Lymph node pain	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Cardiac disorders Pericardial effusion	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/53 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	7.1% 1/14 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect
Investigations Weight increased	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	33.3% 1/3 • Number of events 2 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/3 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	1.9% 1/53 • Number of events 1 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/38 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/14 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect	0.00% 0/28 • Day 1 through 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) after the last dose of study drug (up to 27 months) An AE considered "serious" (SAE) if, in the view of either the Investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect

Additional Information

Pyxis Oncology Clinical Operations

Pyxis Oncology, Inc.

Phone: (339) 545 8252

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place