Trial Outcomes & Findings for Sym023 (Anti-TIM-3) in Patients With Advanced Solid Tumor Malignancies or Lymphomas (NCT NCT03489343)

NCT ID: NCT03489343

Last Updated: 2021-10-12

Results Overview

Assess the safety and tolerability of Sym023 on a Q2W (once every 2 weeks) schedule to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D). Assessment based on the occurrence of AEs meeting DLT criteria measured during Cycle 1. The MTD was to be determined by those DLTs that occurred during C1 in either more than 1 patient in a 3 to 6 patient cohort or ≥33.3% of patients in the event of an expanded 7 to 12 patient cohort. One patient in the 10.0 mg/kg dose cohort was not evaluable for MTD as she did not complete C1 for a reason other than drug toxicity (i.e., discontinuation after 1 dose due to patient withdrawal of consent). However, this patient was included in the evaluation of other outcomes.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 24 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2021-10-12

Participant Flow

Participant milestones

Measure	Sym023 0.03 mg/kg Sym023 0.03 mg/kg intravenous infusion once every 2 weeks	Sym023 0.1 mg/kg Sym023 0.1 mg/kg intravenous infusion once every 2 weeks	Sym023 0.3 mg/kg Sym023 0.3 mg/kg intravenous infusion once every 2 weeks	Sym023 1.0 mg/kg Sym023 1.0 mg/kg intravenous infusion once every 2 weeks	Sym023 3.0 mg/kg Sym023 3.0 mg/kg intravenous infusion once every 2 weeks	Sym023 10.0 mg/kg Sym023 10.0 mg/kg intravenous infusion once every 2 weeks	Sym023 20.0 mg/kg Sym023 20.0 mg/kg intravenous infusion once every 2 weeks
Overall Study STARTED	1	1	3	3	3	7	6
Overall Study COMPLETED	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	1	1	3	3	3	7	6

Reasons for withdrawal

Measure	Sym023 0.03 mg/kg Sym023 0.03 mg/kg intravenous infusion once every 2 weeks	Sym023 0.1 mg/kg Sym023 0.1 mg/kg intravenous infusion once every 2 weeks	Sym023 0.3 mg/kg Sym023 0.3 mg/kg intravenous infusion once every 2 weeks	Sym023 1.0 mg/kg Sym023 1.0 mg/kg intravenous infusion once every 2 weeks	Sym023 3.0 mg/kg Sym023 3.0 mg/kg intravenous infusion once every 2 weeks	Sym023 10.0 mg/kg Sym023 10.0 mg/kg intravenous infusion once every 2 weeks	Sym023 20.0 mg/kg Sym023 20.0 mg/kg intravenous infusion once every 2 weeks
Overall Study Documented progressive disease	1	0	3	1	3	5	4
Overall Study Adverse Event	0	1	0	0	0	1	0
Overall Study Withdrawal by Subject	0	0	0	1	0	1	1
Overall Study Clinical progression	0	0	0	1	0	0	1

Baseline Characteristics

Sym023 (Anti-TIM-3) in Patients With Advanced Solid Tumor Malignancies or Lymphomas

Baseline characteristics by cohort

Measure	Sym023 0.03 mg/kg n=1 Participants Sym023 0.03 mg/kg intravenous infusion once every 2 weeks	Sym023 0.1 mg/kg n=1 Participants Sym023 0.1 mg/kg intravenous infusion once every 2 weeks	Sym023 0.3 mg/kg n=3 Participants Sym023 0.3 mg/kg intravenous infusion once every 2 weeks	Sym023 1.0 mg/kg n=3 Participants Sym023 1.0 mg/kg intravenous infusion once every 2 weeks	Sym023 3.0 mg/kg n=3 Participants Sym023 3.0 mg/kg intravenous infusion once every 2 weeks	Sym023 10.0 mg/kg n=7 Participants Sym023 10.0 mg/kg intravenous infusion once every 2 weeks	Sym023 20.0 mg/kg n=6 Participants Sym023 20.0 mg/kg intravenous infusion once every 2 weeks	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=10 Participants	5 Participants n=115 Participants	16 Participants n=24 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=10 Participants	1 Participants n=115 Participants	8 Participants n=24 Participants
Age, Continuous	64 years n=5 Participants	64 years n=7 Participants	62 years n=5 Participants	66 years n=4 Participants	71 years n=21 Participants	54 years n=10 Participants	61 years n=115 Participants	63 years n=24 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=10 Participants	4 Participants n=115 Participants	16 Participants n=24 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=10 Participants	2 Participants n=115 Participants	8 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	7 Participants n=10 Participants	6 Participants n=115 Participants	23 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=10 Participants	0 Participants n=115 Participants	3 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants	1 Participants n=115 Participants	3 Participants n=24 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=10 Participants	5 Participants n=115 Participants	17 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants
Region of Enrollment Canada	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	1 participants n=21 Participants	2 participants n=10 Participants	1 participants n=115 Participants	5 participants n=24 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants	2 participants n=4 Participants	2 participants n=21 Participants	5 participants n=10 Participants	5 participants n=115 Participants	19 participants n=24 Participants
ECOG PS 1	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	6 Participants n=10 Participants	4 Participants n=115 Participants	19 Participants n=24 Participants
ECOG PS 0	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants	5 Participants n=24 Participants

PRIMARY outcome

Timeframe: 28 days

Population: DLT analysis set of patients who completed treatment dosing in a 4-week (28 day) period that was Cycle 1. One patient out of 7 patients in Group 10mg/kg did not complete Cycle 1 and are not included in the "participants analyzed"

Assess the safety and tolerability of Sym023 on a Q2W (once every 2 weeks) schedule to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D). Assessment based on the occurrence of AEs meeting DLT criteria measured during Cycle 1. The MTD was to be determined by those DLTs that occurred during C1 in either more than 1 patient in a 3 to 6 patient cohort or ≥33.3% of patients in the event of an expanded 7 to 12 patient cohort. One patient in the 10.0 mg/kg dose cohort was not evaluable for MTD as she did not complete C1 for a reason other than drug toxicity (i.e., discontinuation after 1 dose due to patient withdrawal of consent). However, this patient was included in the evaluation of other outcomes.

Outcome measures

Measure	Sym023 0.03 mg/kg n=1 Participants Sym023 0.03 mg/kg intravenous infusion once every 2 weeks	Sym023 0.1 mg/kg n=1 Participants Sym023 0.1 mg/kg intravenous infusion once every 2 weeks	Sym023 0.3 mg/kg n=3 Participants Sym023 0.3 mg/kg intravenous infusion once every 2 weeks	Sym023 1.0 mg/kg n=3 Participants Sym023 1.0 mg/kg intravenous infusion once every 2 weeks	Sym023 3.0 mg/kg n=3 Participants Sym023 3.0 mg/kg intravenous infusion once every 2 weeks	Sym023 10.0 mg/kg n=6 Participants Sym023 10.0 mg/kg intravenous infusion once every 2 weeks	Sym023 20.0 mg/kg n=6 Participants Sym023 20.0 mg/kg intravenous infusion once every 2 weeks
Assessment of Treatment Emergent Adverse Events (AEs) Meeting Dose-limiting Toxicity (DLT) Criteria.	0 Number of DLTs	0 Number of DLTs	0 Number of DLTs	0 Number of DLTs	0 Number of DLTs	0 Number of DLTs	0 Number of DLTs

SECONDARY outcome

Timeframe: Baseline up to 6-months follow-up, approximately 1 year

Population: Full analysis set of all randomised and treated patients

Serum sampling to assess the potential for anti-drug antibody (ADA) formation. The number of patients with positive samples at indicated visits is presented.

Outcome measures

Measure	Sym023 0.03 mg/kg n=1 Participants Sym023 0.03 mg/kg intravenous infusion once every 2 weeks	Sym023 0.1 mg/kg n=1 Participants Sym023 0.1 mg/kg intravenous infusion once every 2 weeks	Sym023 0.3 mg/kg n=3 Participants Sym023 0.3 mg/kg intravenous infusion once every 2 weeks	Sym023 1.0 mg/kg n=3 Participants Sym023 1.0 mg/kg intravenous infusion once every 2 weeks	Sym023 3.0 mg/kg n=3 Participants Sym023 3.0 mg/kg intravenous infusion once every 2 weeks	Sym023 10.0 mg/kg n=7 Participants Sym023 10.0 mg/kg intravenous infusion once every 2 weeks	Sym023 20.0 mg/kg n=6 Participants Sym023 20.0 mg/kg intravenous infusion once every 2 weeks
Evaluation of the Immunogenicity of Sym023. End of treatment	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Evaluation of the Immunogenicity of Sym023. Cycle 2 day 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Evaluation of the Immunogenicity of Sym023. Cycle 3 days 1 and 15	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Evaluation of the Immunogenicity of Sym023. Cycle 4 days 1 and 15	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Evaluation of the Immunogenicity of Sym023. Cycle 5 day 1	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Evaluation of the Immunogenicity of Sym023. Cycle 6 day 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Evaluation of the Immunogenicity of Sym023. Cycle 7 day 1	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Evaluation of the Immunogenicity of Sym023. 1-month follow up	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Evaluation of the Immunogenicity of Sym023. 3-month follow up	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Evaluation of the Immunogenicity of Sym023. Cycle 1 days 1 and 15	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 months

Population: Full analysis set of randomised and treated patients who was evaluable for response. One patient out of 7 in group 10mg/kg was not evaluable for response

OR or SD Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). The number of patients with confirmed or unconfirmed OR (partial or complete response) is presented. Duration of SD for patients with best overall response = SD was defined as the time from the day of first study treatment to the start of radiologic disease progression or death. If the patient did not have a radiological disease progression or death, the duration of SD was defined as the time from the day of first study treatment to the date of the last SD assessment.

Outcome measures

Measure	Sym023 0.03 mg/kg n=1 Participants Sym023 0.03 mg/kg intravenous infusion once every 2 weeks	Sym023 0.1 mg/kg n=1 Participants Sym023 0.1 mg/kg intravenous infusion once every 2 weeks	Sym023 0.3 mg/kg n=3 Participants Sym023 0.3 mg/kg intravenous infusion once every 2 weeks	Sym023 1.0 mg/kg n=3 Participants Sym023 1.0 mg/kg intravenous infusion once every 2 weeks	Sym023 3.0 mg/kg n=3 Participants Sym023 3.0 mg/kg intravenous infusion once every 2 weeks	Sym023 10.0 mg/kg n=6 Participants Sym023 10.0 mg/kg intravenous infusion once every 2 weeks	Sym023 20.0 mg/kg n=6 Participants Sym023 20.0 mg/kg intravenous infusion once every 2 weeks
Evaluation of Objective Response (OR) or Stable Disease (SD) by RECIST v1.1 OR rate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Evaluation of Objective Response (OR) or Stable Disease (SD) by RECIST v1.1 SD >16 weeks	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Evaluation of Objective Response (OR) or Stable Disease (SD) by RECIST v1.1 SD ≤16 weeks	0 Participants	0 Participants	0 Participants	2 Participants	2 Participants	0 Participants	3 Participants

SECONDARY outcome

Timeframe: 24 months

Population: Full analysis set of randomised and treated patients who were evaluable for response. One patient out of 7 in group 10mg/kg was not evaluable for response

OR or SD Assessed by Immunotherapeutics Response Evaluation Criteria in Solid Tumors (iRECIST). The number of patients with confirmed or unconfirmed OR (partial or complete response) is presented. Duration of SD for patients with best overall response = SD was defined as the time from the day of first study treatment to the start of radiologic disease progression or death. If the patient did not have a radiological disease progression or death, the duration of SD was defined as the time from the day of first study treatment to the date of the last SD assessment.

Outcome measures

Measure	Sym023 0.03 mg/kg n=1 Participants Sym023 0.03 mg/kg intravenous infusion once every 2 weeks	Sym023 0.1 mg/kg n=1 Participants Sym023 0.1 mg/kg intravenous infusion once every 2 weeks	Sym023 0.3 mg/kg n=3 Participants Sym023 0.3 mg/kg intravenous infusion once every 2 weeks	Sym023 1.0 mg/kg n=3 Participants Sym023 1.0 mg/kg intravenous infusion once every 2 weeks	Sym023 3.0 mg/kg n=3 Participants Sym023 3.0 mg/kg intravenous infusion once every 2 weeks	Sym023 10.0 mg/kg n=6 Participants Sym023 10.0 mg/kg intravenous infusion once every 2 weeks	Sym023 20.0 mg/kg n=6 Participants Sym023 20.0 mg/kg intravenous infusion once every 2 weeks
Evaluation of Objective Response (OR) or Stable Disease (SD) by iRECIST OR rate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Evaluation of Objective Response (OR) or Stable Disease (SD) by iRECIST iSD >16 weeks	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Evaluation of Objective Response (OR) or Stable Disease (SD) by iRECIST iSD ≤16 weeks	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants	4 Participants

SECONDARY outcome

Timeframe: 24 months

Population: No lymphomas were recorded in this trial, therefore it was not possible to do the RECIL evaluation.

OR or SD Assessed by Response Evaluation Criteria in Lymphomas 2017 (RECIL 2017)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: The full analysis set of randomized and treated patients who were evaluable for response. One patient out of 7 in group 10mg/kg was not evaluable for response or time to progression (TTP) as the patient left trial due to Adverse Event

Based on time of enrollment to first evidence of progression on imaging studies, as assessed by RECIST v1.1, RECIL 2017, or iRECIST, depending on tumor type. The numbers shown below correspond to the values related to RECIST v1.1.

Outcome measures

Measure	Sym023 0.03 mg/kg n=1 Participants Sym023 0.03 mg/kg intravenous infusion once every 2 weeks	Sym023 0.1 mg/kg n=1 Participants Sym023 0.1 mg/kg intravenous infusion once every 2 weeks	Sym023 0.3 mg/kg n=3 Participants Sym023 0.3 mg/kg intravenous infusion once every 2 weeks	Sym023 1.0 mg/kg n=3 Participants Sym023 1.0 mg/kg intravenous infusion once every 2 weeks	Sym023 3.0 mg/kg n=3 Participants Sym023 3.0 mg/kg intravenous infusion once every 2 weeks	Sym023 10.0 mg/kg n=6 Participants Sym023 10.0 mg/kg intravenous infusion once every 2 weeks	Sym023 20.0 mg/kg n=6 Participants Sym023 20.0 mg/kg intravenous infusion once every 2 weeks
Time to Progression (TTP) of Disease.	1.81 months Interval 1.81 to 1.81	7.89 months Interval 7.89 to 7.89	1.18 months Interval 0.72 to 1.38	3.48 months Interval 1.87 to 3.55	1.28 months Interval 1.12 to 3.52	1.68 months Interval 0.03 to 2.07	5.36 months Interval 1.61 to 5.55

SECONDARY outcome

Timeframe: From before the start of the infusion to 168 hours after the end of the infusion

Population: Pharmacokinetic analysis set (same as the full analysis set) of all randomised and treated patients

The AUC after first dose was estimated using non-compartmental methods. Blood samples for PK analysis were taken at the following timepoints: before the start of the infusion, at the end of the infusion and at 2, 4, 8, 24, 48 and 168 hours after the end of the infusion. Actual timepoints were recorded.

Outcome measures

Measure	Sym023 0.03 mg/kg n=1 Participants Sym023 0.03 mg/kg intravenous infusion once every 2 weeks	Sym023 0.1 mg/kg n=1 Participants Sym023 0.1 mg/kg intravenous infusion once every 2 weeks	Sym023 0.3 mg/kg n=3 Participants Sym023 0.3 mg/kg intravenous infusion once every 2 weeks	Sym023 1.0 mg/kg n=3 Participants Sym023 1.0 mg/kg intravenous infusion once every 2 weeks	Sym023 3.0 mg/kg n=3 Participants Sym023 3.0 mg/kg intravenous infusion once every 2 weeks	Sym023 10.0 mg/kg n=7 Participants Sym023 10.0 mg/kg intravenous infusion once every 2 weeks	Sym023 20.0 mg/kg n=6 Participants Sym023 20.0 mg/kg intravenous infusion once every 2 weeks
Area Under the Concentration-time Curve in a Dosing Interval (AUC).	70 h*μg/mL Interval 70.0 to 70.0	176 h*μg/mL Interval 176.0 to 176.0	878 h*μg/mL Interval 680.0 to 1158.0	3193 h*μg/mL Interval 2449.0 to 4194.0	8062 h*μg/mL Interval 4498.0 to 12358.0	30581 h*μg/mL Interval 7039.0 to 45928.0	77262 h*μg/mL Interval 54275.0 to 85463.0

SECONDARY outcome

Timeframe: From before the start of the infusion to 168 hours after the end of the infusion

Population: Pharmacokinetic analysis set (same as the full analysis set) of all randomised and treated patients

Outcome measure after first dose was derived from observed data. Blood samples for PK analysis were taken at the following timepoints: before the start of the infusion, at the end of the infusion and at 2, 4, 8, 24, 48 and 168 hours after the end of the infusion. Actual timepoints were recorded.

Outcome measures

Measure	Sym023 0.03 mg/kg n=1 Participants Sym023 0.03 mg/kg intravenous infusion once every 2 weeks	Sym023 0.1 mg/kg n=1 Participants Sym023 0.1 mg/kg intravenous infusion once every 2 weeks	Sym023 0.3 mg/kg n=3 Participants Sym023 0.3 mg/kg intravenous infusion once every 2 weeks	Sym023 1.0 mg/kg n=3 Participants Sym023 1.0 mg/kg intravenous infusion once every 2 weeks	Sym023 3.0 mg/kg n=3 Participants Sym023 3.0 mg/kg intravenous infusion once every 2 weeks	Sym023 10.0 mg/kg n=7 Participants Sym023 10.0 mg/kg intravenous infusion once every 2 weeks	Sym023 20.0 mg/kg n=6 Participants Sym023 20.0 mg/kg intravenous infusion once every 2 weeks
Maximum Concentration (Cmax)	0.85 μg/mL Interval 0.85 to 0.85	1.98 μg/mL Interval 1.98 to 1.98	7.94 μg/mL Interval 5.67 to 11.56	23.71 μg/mL Interval 19.87 to 28.3	68.03 μg/mL Interval 52.88 to 84.16	232.11 μg/mL Interval 183.26 to 288.01	470.24 μg/mL Interval 294.82 to 543.46

SECONDARY outcome

Timeframe: From before the start of the infusion to 168 hours after the end of the infusion

Population: Pharmacokinetic analysis set (same as the full analysis set) of all randomised and treated patients

Outcome measure after first dose was derived from observed data. Blood samples for PK analysis were taken at the following timepoints: before the start of the infusion, at the end of the infusion and at 2, 4, 8, 24, 48 and 168 hours after the end of the infusion. Actual timepoints were recorded.

Outcome measures

Measure	Sym023 0.03 mg/kg n=1 Participants Sym023 0.03 mg/kg intravenous infusion once every 2 weeks	Sym023 0.1 mg/kg n=1 Participants Sym023 0.1 mg/kg intravenous infusion once every 2 weeks	Sym023 0.3 mg/kg n=3 Participants Sym023 0.3 mg/kg intravenous infusion once every 2 weeks	Sym023 1.0 mg/kg n=3 Participants Sym023 1.0 mg/kg intravenous infusion once every 2 weeks	Sym023 3.0 mg/kg n=3 Participants Sym023 3.0 mg/kg intravenous infusion once every 2 weeks	Sym023 10.0 mg/kg n=7 Participants Sym023 10.0 mg/kg intravenous infusion once every 2 weeks	Sym023 20.0 mg/kg n=6 Participants Sym023 20.0 mg/kg intravenous infusion once every 2 weeks
Time to Reach Maximum Concentration (Tmax)	4.5 hours Interval 4.5 to 4.5	0.6 hours Interval 0.6 to 0.6	1.2 hours Interval 0.5 to 2.5	4.5 hours Interval 4.4 to 4.7	1.8 hours Interval 0.6 to 2.6	3.4 hours Interval 0.5 to 8.5	7.3 hours Interval 0.5 to 20.8

SECONDARY outcome

Timeframe: From before the start of the infusion to 168 hours after the end of the infusion

Population: Pharmacokinetic analysis set (same as the full analysis set) of all randomized and treated patients. Data for cohort 0.03mg/kg: Ctrough at 168 hours were below the limit of quantification, hence no reported data

Outcome measure after first dose was derived from observed data. Blood samples for PK analysis were taken at the following timepoints: before the start of the infusion, at the end of the infusion and at 2, 4, 8, 24, 48 and 168 hours after the end of the infusion. Actual timepoints were recorded.

Outcome measures

Measure	Sym023 0.03 mg/kg n=1 Participants Sym023 0.03 mg/kg intravenous infusion once every 2 weeks	Sym023 0.1 mg/kg n=1 Participants Sym023 0.1 mg/kg intravenous infusion once every 2 weeks	Sym023 0.3 mg/kg n=3 Participants Sym023 0.3 mg/kg intravenous infusion once every 2 weeks	Sym023 1.0 mg/kg n=3 Participants Sym023 1.0 mg/kg intravenous infusion once every 2 weeks	Sym023 3.0 mg/kg n=3 Participants Sym023 3.0 mg/kg intravenous infusion once every 2 weeks	Sym023 10.0 mg/kg n=5 Participants Sym023 10.0 mg/kg intravenous infusion once every 2 weeks	Sym023 20.0 mg/kg n=6 Participants Sym023 20.0 mg/kg intravenous infusion once every 2 weeks
Trough Concentration (Ctrough)	NA μg/mL Ctrough at 168 hours were below the limit of quantification, hence no reported data	0.16 μg/mL Interval 0.16 to 0.16	1.26 μg/mL Interval 0.76 to 1.85	6.39 μg/mL Interval 4.26 to 9.37	12.88 μg/mL Interval 4.09 to 26.1	74.33 μg/mL Interval 37.47 to 116.52	146.96 μg/mL Interval 101.68 to 189.29

SECONDARY outcome

Timeframe: From before the start of the infusion to 168 hours after the end of the infusion

Population: Pharmacokinetic analysis set (same as the full analysis set) of all randomised and treated patients. Data for cohort 0.03mg/kg: T½ could not be accurately calculated due to few datapoint within the elimination period

Outcome measure after first dose was estimated using non-compartmental methods. Blood samples for PK analysis were taken at the following timepoints: before the start of the infusion, at the end of the infusion and at 2, 4, 8, 24, 48 and 168 hours after the end of the infusion. Actual timepoints were recorded.

Outcome measures

Measure	Sym023 0.03 mg/kg n=1 Participants Sym023 0.03 mg/kg intravenous infusion once every 2 weeks	Sym023 0.1 mg/kg n=1 Participants Sym023 0.1 mg/kg intravenous infusion once every 2 weeks	Sym023 0.3 mg/kg n=3 Participants Sym023 0.3 mg/kg intravenous infusion once every 2 weeks	Sym023 1.0 mg/kg Sym023 1.0 mg/kg intravenous infusion once every 2 weeks	Sym023 3.0 mg/kg n=2 Participants Sym023 3.0 mg/kg intravenous infusion once every 2 weeks	Sym023 10.0 mg/kg n=2 Participants Sym023 10.0 mg/kg intravenous infusion once every 2 weeks	Sym023 20.0 mg/kg n=1 Participants Sym023 20.0 mg/kg intravenous infusion once every 2 weeks
Terminal Elimination Half-life (T½)	NA hours T½ could not be accurately calculated due to few datapoints within the elimination	105.10 hours Interval 105.1 to 105.1	153.49 hours Interval 136.7 to 164.11	—	140.60 hours Interval 112.78 to 168.42	185.22 hours Interval 153.43 to 217.01	203.07 hours Interval 203.07 to 203.07

SECONDARY outcome

Timeframe: From before the start of the infusion to 168 hours after the end of the infusion

Population: Pharmacokinetic analysis set (same as the full analysis set) of all randomized and treated patients. Data for cohort 0.03mg/kg: Clearence could not be accurately calculated since too few datapoint within the elimination period

Outcome measure after first dose was estimated using non-compartmental methods. Blood samples for PK analysis were taken at the following timepoints: before the start of the infusion, at the end of the infusion and at 2, 4, 8, 24, 48 and 168 hours after the end of the infusion. Actual timepoints were recorded.

Outcome measures

Measure	Sym023 0.03 mg/kg Sym023 0.03 mg/kg intravenous infusion once every 2 weeks	Sym023 0.1 mg/kg n=1 Participants Sym023 0.1 mg/kg intravenous infusion once every 2 weeks	Sym023 0.3 mg/kg n=1 Participants Sym023 0.3 mg/kg intravenous infusion once every 2 weeks	Sym023 1.0 mg/kg Sym023 1.0 mg/kg intravenous infusion once every 2 weeks	Sym023 3.0 mg/kg n=1 Participants Sym023 3.0 mg/kg intravenous infusion once every 2 weeks	Sym023 10.0 mg/kg Sym023 10.0 mg/kg intravenous infusion once every 2 weeks	Sym023 20.0 mg/kg Sym023 20.0 mg/kg intravenous infusion once every 2 weeks
Clearance (CL)	—	0.501 mL/h)/kg Interval 0.501 to 0.501	0.364 mL/h)/kg Interval 0.364 to 0.364	—	0.582 mL/h)/kg Interval 0.582 to 0.582	—	—

Adverse Events

Sym023 0.03 mg/kg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Sym023 0.1 mg/kg

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Sym023 0.3 mg/kg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 3 deaths

Sym023 1.0 mg/kg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Sym023 3.0 mg/kg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 2 deaths

Sym023 10.0 mg/kg

Serious events: 2 serious events

Other events: 7 other events

Deaths: 1 deaths

Sym023 20.0 mg/kg

Serious events: 1 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Measure	Sym023 0.03 mg/kg n=1 participants at risk Sym023 0.03 mg/kg intravenous infusion once every 2 weeks	Sym023 0.1 mg/kg n=1 participants at risk Sym023 0.1 mg/kg intravenous infusion once every 2 weeks	Sym023 0.3 mg/kg n=3 participants at risk Sym023 0.3 mg/kg intravenous infusion once every 2 weeks	Sym023 1.0 mg/kg n=3 participants at risk Sym023 1.0 mg/kg intravenous infusion once every 2 weeks	Sym023 3.0 mg/kg n=3 participants at risk Sym023 3.0 mg/kg intravenous infusion once every 2 weeks	Sym023 10.0 mg/kg n=7 participants at risk Sym023 10.0 mg/kg intravenous infusion once every 2 weeks	Sym023 20.0 mg/kg n=6 participants at risk Sym023 20.0 mg/kg intravenous infusion once every 2 weeks
Musculoskeletal and connective tissue disorders Immune-mediated arthritis	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	100.0% 1/1 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/7 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/6 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	14.3% 1/7 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/6 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.
Investigations Lipase increased	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	14.3% 1/7 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/6 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/7 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	16.7% 1/6 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.
Nervous system disorders Spinal cord compression	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/7 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	16.7% 1/6 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.

Other adverse events

Measure	Sym023 0.03 mg/kg n=1 participants at risk Sym023 0.03 mg/kg intravenous infusion once every 2 weeks	Sym023 0.1 mg/kg n=1 participants at risk Sym023 0.1 mg/kg intravenous infusion once every 2 weeks	Sym023 0.3 mg/kg n=3 participants at risk Sym023 0.3 mg/kg intravenous infusion once every 2 weeks	Sym023 1.0 mg/kg n=3 participants at risk Sym023 1.0 mg/kg intravenous infusion once every 2 weeks	Sym023 3.0 mg/kg n=3 participants at risk Sym023 3.0 mg/kg intravenous infusion once every 2 weeks	Sym023 10.0 mg/kg n=7 participants at risk Sym023 10.0 mg/kg intravenous infusion once every 2 weeks	Sym023 20.0 mg/kg n=6 participants at risk Sym023 20.0 mg/kg intravenous infusion once every 2 weeks
Investigations Lymphocyte count decreased	100.0% 1/1 • Number of events 3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	14.3% 1/7 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/6 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.
Blood and lymphatic system disorders Anemia	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	33.3% 1/3 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	33.3% 1/3 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	14.3% 1/7 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	33.3% 2/6 • Number of events 3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.
Gastrointestinal disorders Constipation	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	33.3% 1/3 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	14.3% 1/7 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	16.7% 1/6 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.
Gastrointestinal disorders Nausea	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	33.3% 1/3 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	33.3% 1/3 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/7 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	16.7% 1/6 • Number of events 2 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.
Gastrointestinal disorders Diarrhoea	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	28.6% 2/7 • Number of events 2 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/6 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.
General disorders Fatigue	100.0% 1/1 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	100.0% 1/1 • Number of events 4 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	66.7% 2/3 • Number of events 3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	33.3% 1/3 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	33.3% 1/3 • Number of events 2 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	28.6% 2/7 • Number of events 2 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	16.7% 1/6 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.
Gastrointestinal disorders Pyrexia	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	33.3% 1/3 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	14.3% 1/7 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/6 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.
Hepatobiliary disorders Hyperbilirubinemia	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	33.3% 1/3 • Number of events 3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	33.3% 1/3 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/7 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/6 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.
Infections and infestations Urinary tract infection	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	33.3% 1/3 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	33.3% 1/3 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/7 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	16.7% 1/6 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.
Infections and infestations Pneumonia	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	33.3% 1/3 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	14.3% 1/7 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/6 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.
Investigations Lipase increased	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	14.3% 1/7 • Number of events 2 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/6 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	33.3% 1/3 • Number of events 2 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	33.3% 1/3 • Number of events 3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	14.3% 1/7 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	16.7% 1/6 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	14.3% 1/7 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	16.7% 1/6 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	33.3% 1/3 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/7 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	16.7% 1/6 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	33.3% 1/3 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/7 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	16.7% 1/6 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	14.3% 1/7 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	16.7% 1/6 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.
Psychiatric disorders Anxiety	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/7 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	33.3% 2/6 • Number of events 2 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	33.3% 1/3 • Number of events 2 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	33.3% 1/3 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	28.6% 2/7 • Number of events 2 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/6 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.
Vascular disorders Hypertension	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	33.3% 1/3 • Number of events 1 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/3 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	28.6% 2/7 • Number of events 2 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.	0.00% 0/6 • 24 months Only treatment-emergent adverse events (AEs) are presented in clinicaltrials.gov, defined as AEs with onset dates on or after the first dose of study medication or AEs that occurred before the first dose of study medication and increased in severity after the first dose of study medication up to the last dose of study drug plus 30 days.

Additional Information

Medical Director

Symphogen AS

Phone: 0045 45265050

Email: info@symphogen.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place