Trial Outcomes & Findings for Study of Safety and Efficacy of Betalutin and Rituximab in Patients With FL (NCT NCT03806179)

NCT ID: NCT03806179

Last Updated: 2023-12-22

Results Overview

Safety and tolerability of Betalutin in combination with rituximab as determined by the frequency and severity of adverse events (CTCAE v4.03) in the first 12 weeks after Betalutin

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 7 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2023-12-22

Participant Flow

Participant milestones

Measure	10 MBq/kg Betalutin With Rituximab Treatment 10 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years 10 MBq/kg Betalutin: 10 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2	15 MBq/kg Betalutin With Rituximab Treatment 15 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years 15 MBq/kg Betalutin: 15 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2
Overall Study STARTED	4	3
Overall Study COMPLETED	4	1
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	10 MBq/kg Betalutin With Rituximab Treatment 10 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years 10 MBq/kg Betalutin: 10 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2	15 MBq/kg Betalutin With Rituximab Treatment 15 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years 15 MBq/kg Betalutin: 15 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2
Overall Study Progressive disease	0	2

Baseline Characteristics

Study of Safety and Efficacy of Betalutin and Rituximab in Patients With FL

Baseline characteristics by cohort

Measure	10 MBq/kg Betalutin With Rituximab Treatment n=4 Participants 10 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years 10 MBq/kg Betalutin: 10 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2	15 MBq/kg Betalutin With Rituximab Treatment n=3 Participants 15 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years 15 MBq/kg Betalutin: 15 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	4 Participants n=5 Participants	3 Participants n=7 Participants	7 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
Region of Enrollment Norway	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment Czechia	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Safety and tolerability of Betalutin in combination with rituximab as determined by the frequency and severity of adverse events (CTCAE v4.03) in the first 12 weeks after Betalutin

Outcome measures

Measure	10 MBq/kg Betalutin With Rituximab Treatment n=4 Participants 10 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years 10 MBq/kg Betalutin: 10 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2	15 MBq/kg Betalutin With Rituximab Treatment n=3 Participants 15 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years 15 MBq/kg Betalutin: 15 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2
Safety and Tolerability: Frequency and Severity of Adverse Events (CTCAE v4.03) Number of participants with dose limiting toxicities in the first 12 weeks	0 Participants	0 Participants
Safety and Tolerability: Frequency and Severity of Adverse Events (CTCAE v4.03) Number of participants with adverse events in the first 12 weeks	3 Participants	3 Participants
Safety and Tolerability: Frequency and Severity of Adverse Events (CTCAE v4.03) Number of participants with SAEs in the first 12 weeks	0 Participants	0 Participants
Safety and Tolerability: Frequency and Severity of Adverse Events (CTCAE v4.03) Number of participants with Betalutin related adverse events in the first 12 weeks	1 Participants	3 Participants
Safety and Tolerability: Frequency and Severity of Adverse Events (CTCAE v4.03) Number of participants with CTCAE Grade 3 or 4 adverse events in the first 12 weeks	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 25 months

Best overall response of combination treatment using tumour responses based on CT and PET/CT imaging (classified as as complete response, partial response, no response/stable disease or progressive disease as described in "Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification")

Outcome measures

Measure	10 MBq/kg Betalutin With Rituximab Treatment n=4 Participants 10 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years 10 MBq/kg Betalutin: 10 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2	15 MBq/kg Betalutin With Rituximab Treatment n=3 Participants 15 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years 15 MBq/kg Betalutin: 15 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2
Preliminary Anti-tumour Activity Complete response	3 Participants	2 Participants
Preliminary Anti-tumour Activity Partial response	1 Participants	1 Participants

Adverse Events

10 MBq/kg Betalutin With Rituximab Treatment

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

15 MBq/kg Betalutin With Rituximab Treatment

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	10 MBq/kg Betalutin With Rituximab Treatment n=4 participants at risk 10 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years 10 MBq/kg Betalutin: 10 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2	15 MBq/kg Betalutin With Rituximab Treatment n=3 participants at risk 15 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years 15 MBq/kg Betalutin: 15 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2
Infections and infestations Erysipelas	25.0% 1/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	0.00% 0/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Injury, poisoning and procedural complications Fall	25.0% 1/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	0.00% 0/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Infections and infestations Bronchitis viral	25.0% 1/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	0.00% 0/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.

Other adverse events

Measure	10 MBq/kg Betalutin With Rituximab Treatment n=4 participants at risk 10 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years 10 MBq/kg Betalutin: 10 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2	15 MBq/kg Betalutin With Rituximab Treatment n=3 participants at risk 15 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years 15 MBq/kg Betalutin: 15 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2
Blood and lymphatic system disorders Thrombocytopenia	25.0% 1/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	33.3% 1/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Blood and lymphatic system disorders Leukopenia	0.00% 0/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	33.3% 1/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Blood and lymphatic system disorders Neutropenia	0.00% 0/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	33.3% 1/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Cardiac disorders Palpitations	25.0% 1/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	0.00% 0/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Gastrointestinal disorders Diarrhoea	25.0% 1/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	33.3% 1/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Gastrointestinal disorders Nausea	25.0% 1/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	0.00% 0/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Gastrointestinal disorders Vomiting	25.0% 1/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	0.00% 0/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
General disorders Fatigue	50.0% 2/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	33.3% 1/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
General disorders Facial pain	0.00% 0/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	33.3% 1/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
General disorders Influenza-like illness	25.0% 1/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	0.00% 0/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
General disorders Non-cardiac chest pain	0.00% 0/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	33.3% 1/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Infections and infestations Nasopharyngitis	25.0% 1/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	33.3% 1/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Infections and infestations Erysipelas	25.0% 1/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	0.00% 0/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Infections and infestations Rash pustular	25.0% 1/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	0.00% 0/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	33.3% 1/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Investigations Gamma-glutamyltransferase increased	25.0% 1/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	0.00% 0/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Investigations Neutrophil count decreased	0.00% 0/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	33.3% 1/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Musculoskeletal and connective tissue disorders Muscle spasm	0.00% 0/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	33.3% 1/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Nervous system disorders Restless leg syndrome	25.0% 1/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	0.00% 0/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 1/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	0.00% 0/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	33.3% 1/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Skin and subcutaneous tissue disorders Night sweats	25.0% 1/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	0.00% 0/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Skin and subcutaneous tissue disorders Rash erythematous	25.0% 1/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	0.00% 0/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Renal and urinary disorders Nephrolithiasis	25.0% 1/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	0.00% 0/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Nervous system disorders Dizziness	50.0% 2/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	0.00% 0/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Nervous system disorders Primary progressive aphasia	25.0% 1/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	0.00% 0/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Nervous system disorders Nerve degeneration	25.0% 1/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	0.00% 0/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
General disorders Axillary pain	25.0% 1/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	0.00% 0/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Gastrointestinal disorders Abdominal pain	25.0% 1/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	0.00% 0/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Skin and subcutaneous tissue disorders Hyperhidrosis	25.0% 1/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	0.00% 0/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
General disorders Swelling	25.0% 1/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	0.00% 0/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Nervous system disorders Tremor	25.0% 1/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	0.00% 0/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Investigations Weight decreased	25.0% 1/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	0.00% 0/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Metabolism and nutrition disorders Decreased appetite	25.0% 1/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	0.00% 0/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Nervous system disorders Post-traumatic headache	0.00% 0/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	33.3% 1/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Injury, poisoning and procedural complications Concussion	0.00% 0/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	33.3% 1/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Nervous system disorders Headache	0.00% 0/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	33.3% 1/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
General disorders Pyrexia	0.00% 0/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	33.3% 1/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Injury, poisoning and procedural complications Wound	0.00% 0/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	33.3% 1/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	33.3% 1/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Infections and infestations Skin infection	0.00% 0/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	33.3% 1/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.
Gastrointestinal disorders Hypoaesthesia oral	25.0% 1/4 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.	0.00% 0/3 • All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only. Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.

Additional Information

Head of Clinical Operations

Nordic Nanovector

Phone: +47 22 18 33 01

Email: mail@nordicnanovector.com

Results disclosure agreements

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

Restriction type: LTE60