Trial Outcomes & Findings for A 2nd Generation E1/E2B/E3-Deleted Adenoviral COVID-19 Vaccine: The TCELL VACCINE TRIAL (NCT NCT06022224)

NCT ID: NCT06022224

Last Updated: 2024-06-07

Results Overview

To define the safety profile of prophylactic hAd5-SFusion+N-ETSD in the first 200 subjects randomized (Phase 2)

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 35 participants
• Primary outcome timeframe: Up to 7 months (From day 1 to 6 months after last dose)
• Results posted on: 2024-06-07

Participant Flow

Only the Phase 2 portion of the study enrolled participants. There were no participants enrolled into Phase 3 portion of the study because the study was prematurely terminated.

Participant milestones

Measure	Phase 2 hAd5-S-Fusion+N-ETSD Prime (SC, Day 1) + Boost (SC, Day 22) @ 1x10\^11 VP/dose hAd5-S-Fusion+N-ETSD: Clear and colorless liquid. Each vaccine is supplied in a 2-mL vial containing 1.0 mL of extractable vaccine at a concentration of 1 × 10\^11 viral particles/mL.	Phase 2 Placebo Prime (SC, Day 1) + Boost (SC, Day 22) Placebo (0.9% (w/v) saline): Clear and colorless liquid.
Overall Study STARTED	17	18
Overall Study COMPLETED	17	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A 2nd Generation E1/E2B/E3-Deleted Adenoviral COVID-19 Vaccine: The TCELL VACCINE TRIAL

Baseline characteristics by cohort

Measure	hAd5-S-Fusion+N-ETSD n=17 Participants Prime (SC, Day 1) + Boost (SC, Day 22) @ 1x10\^11 VP/dose hAd5-S-Fusion+N-ETSD: Clear and colorless liquid. Each vaccine is supplied in a 2-mL vial containing 1.0 mL of extractable vaccine at a concentration of 1 × 10\^11 viral particles/mL.	Placebo n=18 Participants Prime (SC, Day 1) + Boost (SC, Day 22) Placebo (0.9% (w/v) saline): Clear and colorless liquid.	Total n=35 Participants Total of all reporting groups
Age, Continuous	55.3 years STANDARD_DEVIATION 8.43 • n=5 Participants	51.0 years STANDARD_DEVIATION 18.12 • n=7 Participants	53.1 years STANDARD_DEVIATION 14.23 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	17 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Healthy volunteers with no prior history of Covid	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 7 months (From day 1 to 6 months after last dose)

Population: Analysis population is all randomized subjects who received at least one dose of study intervention (safety analysis population)

To define the safety profile of prophylactic hAd5-SFusion+N-ETSD in the first 200 subjects randomized (Phase 2)

Outcome measures

Measure	Phase 2 hAd5-S-Fusion+N-ETSD n=17 Participants Prime (SC, Day 1) + Boost (SC, Day 22) @ 1x10\^11 VP/dose hAd5-S-Fusion+N-ETSD: Clear and colorless liquid. Each vaccine is supplied in a 2-mL vial containing 1.0 mL of extractable vaccine at a concentration of 1 × 10\^11 viral particles/mL.	Phase 2 Placebo n=18 Participants Prime (SC, Day 1) + Boost (SC, Day 22) Placebo (0.9% (w/v) saline): Clear and colorless liquid.
Number of Participants With Adverse Events	17 Participants	18 Participants

Adverse Events

Prime (SC, Day 1) + Boost (SC, Day 22) @ 1x10^11 VP/Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Prime (SC, Day 1) + Boost (SC, Day 22) Placebo (0.9% (w/v) Saline): Clear and Colorless Liquid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 1: hAd5-S-Fusion+N-ETSD

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Group 1: Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Group 2: hAd5-S-Fusion+N-ETSD

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Group 2:Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Group 3: hAd5-S-Fusion+N-ETSD

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Group 3: Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Group 4: hAd5-S-Fusion+N-ETSD

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Group 4: Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Group 5: hAd5-S-Fusion+N-ETSD

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Group 5: Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Group 6: hAd5-S-Fusion+N-ETSD

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Group 6: Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Group 7: hAd5-S-Fusion+N-ETSD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 7: Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Prime (SC, Day 1) + Boost (SC, Day 22) @ 1x10^11 VP/Dose n=17 participants at risk hAd5-S-Fusion+N-ETSD : Clear and colorless liquid. Each vaccine is supplied in a 2-mL vial containing 1.0 mL of extractable vaccine at a concentration of 1 × 10\^11 viral particles/mL.	Prime (SC, Day 1) + Boost (SC, Day 22) Placebo (0.9% (w/v) Saline): Clear and Colorless Liquid n=18 participants at risk Placebo	Group 1: hAd5-S-Fusion+N-ETSD n=17 participants at risk Solicited local reactogenicity adverse events from Day 1 through Day 7 after each vaccination	Group 1: Placebo n=18 participants at risk Solicited Local Reactogenicity Adverse Events from Day 1 through Day 7 after Each Vaccination	Group 2: hAd5-S-Fusion+N-ETSD n=17 participants at risk Solicited systemic reactogenicity adverse events from Day 1 through Day 7 after each vaccination	Group 2:Placebo n=18 participants at risk Solicited systemic reactogenicity adverse events from Day 1 through Day 7 after each vaccination	Group 3: hAd5-S-Fusion+N-ETSD n=17 participants at risk Unsolicited Adverse Events from First Vaccination through 7 Days after Last Vaccination	Group 3: Placebo n=18 participants at risk Unsolicited Adverse Events from First Vaccination through 7 Days after Last Vaccination	Group 4: hAd5-S-Fusion+N-ETSD n=17 participants at risk Unsolicited Treatment Related Adverse Events First Vaccination through 7 Days after Last Vaccination	Group 4: Placebo n=18 participants at risk Unsolicited Treatment Related Adverse Events First Vaccination through 7 Days after Last Vaccination	Group 5: hAd5-S-Fusion+N-ETSD n=17 participants at risk Unsolicited Adverse Events from First Vaccination through 1 Month after Last Vaccination	Group 5: Placebo n=18 participants at risk Unsolicited Adverse Events from First Vaccination through 1 Month after Last Vaccination	Group 6: hAd5-S-Fusion+N-ETSD n=17 participants at risk Unsolicited Treatment-Related Adverse Events First Vaccination through1 Month after Last Vaccination	Group 6: Placebo n=18 participants at risk Unsolicited Treatment-Related Adverse Events First Vaccination through1 Month after Last Vaccination	Group 7: hAd5-S-Fusion+N-ETSD n=17 participants at risk Serious Adverse Events from first Vaccination through 6 months after last Vaccination	Group 7: Placebo n=18 participants at risk Serious Adverse Events from first Vaccination through 6 months after last Vaccination
General disorders Injection site reaction	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	88.2% 15/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	88.2% 15/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	88.2% 15/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	88.2% 15/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.
General disorders Injection site erythema	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	88.2% 15/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	16.7% 3/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.
General disorders Injection site pain	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	94.1% 16/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	11.1% 2/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.
General disorders Injection site swelling	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	58.8% 10/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.
General disorders Fatigue	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	70.6% 12/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	11.1% 2/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.9% 1/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.
General disorders Chills	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	35.3% 6/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	11.1% 2/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.
Gastrointestinal disorders Pyrexia	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.9% 1/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.
Nervous system disorders Headache	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	52.9% 9/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	27.8% 5/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	41.2% 7/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	22.2% 4/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.
Gastrointestinal disorders Diarrhoea	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	23.5% 4/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.6% 1/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.
General disorders Injection site pruritus	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	64.7% 11/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	64.7% 11/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	64.7% 11/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	64.7% 11/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.
Gastrointestinal disorders Injection site warmth	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.9% 1/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.9% 1/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.9% 1/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.9% 1/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.
General disorders Swelling	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.9% 1/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.9% 1/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.9% 1/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.9% 1/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.
Gastrointestinal disorders Nausea	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	41.2% 7/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.6% 1/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	41.2% 7/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.6% 1/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	41.2% 7/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.6% 1/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	41.2% 7/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.6% 1/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.
Gastrointestinal disorders Dry Mouth	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.6% 1/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.6% 1/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.9% 1/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.9% 1/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.9% 1/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.9% 1/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.
Infections and infestations Influenza	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.9% 1/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.9% 1/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.9% 1/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.9% 1/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.9% 1/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.9% 1/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.
Psychiatric disorders Insomnia	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.9% 1/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.9% 1/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.9% 1/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.9% 1/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.6% 1/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.6% 1/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.9% 1/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.9% 1/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.9% 1/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	5.9% 1/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/17 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.	0.00% 0/18 • From the time of first dose of study treatment until 1 month after the last dose of study treatment (including Assessment 3), up to 2 months. All SAEs were planned to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment, up to 7 months.

Additional Information

Lennie Sender, Chief Operating Officer

ImmunityBio

Phone: 855-797-9277

Email: lennie.sender@immunitybio.com

Results disclosure agreements

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