Trial Outcomes & Findings for Study of Magrolimab (Hu5F9-G4) in Combination With Cetuximab in Participants With Solid Tumors and Advanced Colorectal Cancer (NCT NCT02953782)
NCT ID: NCT02953782
Last Updated: 2021-03-01
Results Overview
DLT was defined as any Grade (GR) 3 or greater adverse event (AE) that was assessed as related to study treatment with the exceptions of: GR 3: anemia (hemolytic anemia that is medically significant tis considered a DLT), indirect/unconjugated hyperbilirubinemia, electrolyte abnormalities, elevation in alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase that resolved to ≤ Grade 2 with supportive care within 1 week and is not associated with other clinically significant consequences; nausea, vomiting, or diarrhea that resolved to ≤ Grade 2 with supportive care within 72 hours; fatigue that resolved to ≤ Grade 2 within 2 weeks on study; drug-related infusion reactions in the absence of an optimal pretreatment regimen; tumor lysis syndrome or electrolyte disturbances, hypomagnesemia, that resolved to ≤ Grade 2 or baseline within 1 week; GR 3 or 4: lymphopenia or leukopenia.
COMPLETED
PHASE1/PHASE2
78 participants
From first dose up to Day 28
2021-03-01
Participant Flow
Participants were enrolled at study sites in United States. The first participant was screened on 02 November 2016. The last study visit occurred on 10 February 2020.
105 participants were screened.
Participant milestones
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by intravenous (IV) infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented progressive disease (PD).
|
Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
Participants with advanced colorectal cancer (CRC) who were KRAS wild type (KRASwt) and were refractory to anti-EGFRmAb therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
Participants with advanced CRC with KRAS mutation (KRASm) who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1b (Maximum Duration: 14.3 Months)
STARTED
|
6
|
3
|
9
|
8
|
6
|
0
|
0
|
0
|
|
Phase 1b (Maximum Duration: 14.3 Months)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1b (Maximum Duration: 14.3 Months)
NOT COMPLETED
|
6
|
3
|
9
|
8
|
6
|
0
|
0
|
0
|
|
Phase 2 (Maximum Duration: 11.1 Months)
STARTED
|
0
|
0
|
0
|
0
|
0
|
16
|
15
|
15
|
|
Phase 2 (Maximum Duration: 11.1 Months)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2 (Maximum Duration: 11.1 Months)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
16
|
15
|
15
|
Reasons for withdrawal
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by intravenous (IV) infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented progressive disease (PD).
|
Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
Participants with advanced colorectal cancer (CRC) who were KRAS wild type (KRASwt) and were refractory to anti-EGFRmAb therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
Participants with advanced CRC with KRAS mutation (KRASm) who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1b (Maximum Duration: 14.3 Months)
Death
|
5
|
2
|
6
|
6
|
4
|
0
|
0
|
0
|
|
Phase 1b (Maximum Duration: 14.3 Months)
Withdrawal by Subject
|
1
|
0
|
2
|
0
|
1
|
0
|
0
|
0
|
|
Phase 1b (Maximum Duration: 14.3 Months)
Discontinued by Sponsor
|
0
|
1
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Phase 1b (Maximum Duration: 14.3 Months)
Participant placed in hospice care
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Phase 2 (Maximum Duration: 11.1 Months)
Death
|
0
|
0
|
0
|
0
|
0
|
14
|
11
|
8
|
|
Phase 2 (Maximum Duration: 11.1 Months)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
3
|
|
Phase 2 (Maximum Duration: 11.1 Months)
Discontinued by Sponsor
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
4
|
|
Phase 2 (Maximum Duration: 11.1 Months)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study of Magrolimab (Hu5F9-G4) in Combination With Cetuximab in Participants With Solid Tumors and Advanced Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2
n=6 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2
n=3 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2
n=9 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
n=8 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
n=6 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
n=16 Participants
Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
n=15 Participants
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
n=15 Participants
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 6.72 • n=5 Participants
|
68.6 years
STANDARD_DEVIATION 11.39 • n=7 Participants
|
57.3 years
STANDARD_DEVIATION 7.05 • n=5 Participants
|
52.4 years
STANDARD_DEVIATION 10.97 • n=4 Participants
|
63.6 years
STANDARD_DEVIATION 9.50 • n=21 Participants
|
59.7 years
STANDARD_DEVIATION 14.38 • n=10 Participants
|
58.9 years
STANDARD_DEVIATION 14.41 • n=115 Participants
|
57.4 years
STANDARD_DEVIATION 5.80 • n=6 Participants
|
58.9 years
STANDARD_DEVIATION 11.13 • n=6 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
27 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
10 Participants
n=6 Participants
|
51 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
8 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
11 Participants
n=6 Participants
|
65 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
8 Participants
n=6 Participants
|
55 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
12 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: From first dose up to Day 28Population: DLT Evaluable Analysis Set included participants who received at least 1 dose of any study drugs during Phase 1b if the participant either experienced a DLT any time during the DLT assessment period (the first 4 weeks of treatment) or completed at least 4 infusions of magrolimab and 2 infusions of cetuximab.
DLT was defined as any Grade (GR) 3 or greater adverse event (AE) that was assessed as related to study treatment with the exceptions of: GR 3: anemia (hemolytic anemia that is medically significant tis considered a DLT), indirect/unconjugated hyperbilirubinemia, electrolyte abnormalities, elevation in alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase that resolved to ≤ Grade 2 with supportive care within 1 week and is not associated with other clinically significant consequences; nausea, vomiting, or diarrhea that resolved to ≤ Grade 2 with supportive care within 72 hours; fatigue that resolved to ≤ Grade 2 within 2 weeks on study; drug-related infusion reactions in the absence of an optimal pretreatment regimen; tumor lysis syndrome or electrolyte disturbances, hypomagnesemia, that resolved to ≤ Grade 2 or baseline within 1 week; GR 3 or 4: lymphopenia or leukopenia.
Outcome measures
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2
n=6 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2
n=3 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2
n=9 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
n=7 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
n=6 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1.After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 1 Safety Run-in: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
n=9 Participants
Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) in combination with cetuximab 250 mg/m\^2 infusions given over 60 minutes.
|
Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Magrolimab Priming Dose Only
Participants who received only the priming dose (1 mg/kg) of magrolimab in Phase 2 of the study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Dose Limiting Toxicities (DLT)
|
16.7 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
14.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose date up to last dose date plus 30 days (maximum: 15.3 months)Population: All Treated included all participants who received at least 1 dose of any study drugs.
An AE was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE was any unfavorable and unintended sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the investigational medicinal product. A TEAE was defined as AEs worsening or occurring during or after a participant's first exposure to study drug and within 30 days after the last administration of study drug or initiation of new anticancer therapy, whichever occurred first.
Outcome measures
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2
n=6 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2
n=3 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2
n=10 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
n=7 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
n=6 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1.After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 1 Safety Run-in: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
n=14 Participants
Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) in combination with cetuximab 250 mg/m\^2 infusions given over 60 minutes.
|
Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
n=15 Participants
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
n=14 Participants
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Magrolimab Priming Dose Only
n=3 Participants
Participants who received only the priming dose (1 mg/kg) of magrolimab in Phase 2 of the study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
PRIMARY outcome
Timeframe: From Screening until 38.89 months (assessed on Day 1 of Cycle 3 then every 8 weeks [Q8W] from Cycle 5 onwards up to 38.89 months; 1 cycle = 4 weeks)Population: Participants in All Treated with available data were analyzed. Efficacy results were planned to be reported separately for all CRC participants with KRASwt and KRASm tumors.
Objective response rate was defined as the percentage of participants with objective response which consisted of complete response (CR)+ partial response (PR) determined by RECIST v 1.1. CR: Disappearance of all target and all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\< 10 mm short axis). Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2
n=32 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2
n=42 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1.After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 1 Safety Run-in: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) in combination with cetuximab 250 mg/m\^2 infusions given over 60 minutes.
|
Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Magrolimab Priming Dose Only
Participants who received only the priming dose (1 mg/kg) of magrolimab in Phase 2 of the study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
|
6.3 percentage of participants
Interval 0.8 to 20.8
|
0.0 percentage of participants
Interval 0.0 to 8.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-magrolimab dose (within 12 hours) and 1-hour post-magrolimab dose (infusion duration = approximately 3 hours on Day 1 and 2 hours on other days) on Days 1 (Cycle 1 Day 1), 8 (Cycle 1 Day 8), and 29 (Cycle 2 Day 1) (1 cycle = 4 weeks)Population: Participants in the PK Analysis Set (participants who received any amount of magrolimab with at least one detectable post-treatment serum concentration of magrolimab) with available data were analyzed.
Cmax is defined as the maximum concentration of drug.
Outcome measures
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2
n=6 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2
n=3 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2
n=10 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
n=7 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
n=6 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1.After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 1 Safety Run-in: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
n=15 Participants
Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) in combination with cetuximab 250 mg/m\^2 infusions given over 60 minutes.
|
Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
n=14 Participants
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
n=11 Participants
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Magrolimab Priming Dose Only
Participants who received only the priming dose (1 mg/kg) of magrolimab in Phase 2 of the study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter: Cmax of Magrolimab
Day 1 (Cycle 1 Day 1)
|
1.04 μg/mL
Standard Deviation 0.769
|
0.629 μg/mL
Standard Deviation 0.437
|
0.662 μg/mL
Standard Deviation 0.374
|
0.432 μg/mL
Standard Deviation 0.173
|
0.517 μg/mL
Standard Deviation 0.311
|
0.479 μg/mL
Standard Deviation 0.170
|
0.559 μg/mL
Standard Deviation 0.254
|
0.525 μg/mL
Standard Deviation 0.296
|
—
|
|
Pharmacokinetic (PK) Parameter: Cmax of Magrolimab
Day 8 (Cycle 1 Day 8)
|
209 μg/mL
Standard Deviation 82.0
|
230 μg/mL
Standard Deviation 54.6
|
455 μg/mL
Standard Deviation 105
|
558 μg/mL
Standard Deviation 168
|
1100 μg/mL
Standard Deviation 287
|
513 μg/mL
Standard Deviation 148
|
616 μg/mL
Standard Deviation 121
|
901 μg/mL
Standard Deviation 131
|
—
|
|
Pharmacokinetic (PK) Parameter: Cmax of Magrolimab
Day 29 (Cycle 2 Day 1)
|
312 μg/mL
Standard Deviation 121
|
352 μg/mL
Standard Deviation 68.4
|
728 μg/mL
Standard Deviation 207
|
982 μg/mL
Standard Deviation 182
|
2140 μg/mL
Standard Deviation 590
|
—
|
775 μg/mL
Standard Deviation 110
|
1790 μg/mL
Standard Deviation 49.5
|
—
|
SECONDARY outcome
Timeframe: Pre-magrolimab dose (within 12 hours) and 1-hour post-magrolimab dose (infusion duration = approximately 3 hours on Day 1 and 2 hours on other days) on Days 8 (Cycle 1 Day 8) and 29 (Cycle 2 Day 1) (1 cycle = 4 weeks)Population: Participants in the PK Analysis Set with available data were analyzed.
Tmax is defined as the time (observed time point) of Cmax.
Outcome measures
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2
n=6 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2
n=3 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2
n=9 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
n=7 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
n=6 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1.After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 1 Safety Run-in: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
n=9 Participants
Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) in combination with cetuximab 250 mg/m\^2 infusions given over 60 minutes.
|
Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
n=14 Participants
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
n=11 Participants
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Magrolimab Priming Dose Only
Participants who received only the priming dose (1 mg/kg) of magrolimab in Phase 2 of the study.
|
|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter: Tmax of Magrolimab
Day 8 (Cycle 1 Day 8)
|
0.10 days
Interval 0.09 to 0.12
|
0.12 days
Interval 0.09 to 0.13
|
0.12 days
Interval 0.12 to 6.94
|
0.14 days
Interval 0.12 to 0.85
|
0.13 days
Interval 0.12 to 3.9
|
0.12 days
Interval 0.08 to 6.82
|
0.13 days
Interval 0.12 to 0.17
|
0.12 days
Interval 0.11 to 6.99
|
—
|
|
PK Parameter: Tmax of Magrolimab
Day 29 (Cycle 2 Day 1)
|
0.94 days
Interval 0.1 to 1.09
|
0.13 days
Interval 0.12 to 0.13
|
0.13 days
Interval 0.12 to 0.96
|
0.13 days
Interval 0.1 to 0.15
|
0.12 days
Interval 0.12 to 0.13
|
—
|
0.14 days
Interval 0.14 to 0.14
|
0.12 days
Interval 0.12 to 0.12
|
—
|
SECONDARY outcome
Timeframe: Pre-magrolimab dose (within 12 hours) and 1-hour post-magrolimab dose (infusion duration = approximately 3 hours on Day 1 and 2 hours on other days) on Days 8 (Cycle 1 Day 8) and 29 (Cycle 2 Day 1) (1 cycle = 4 weeks)Population: Participants in the PK Analysis Set with available data were analyzed.
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Outcome measures
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2
n=5 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2
n=3 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2
n=9 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
n=6 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
n=6 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1.After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 1 Safety Run-in: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
n=1 Participants
Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) in combination with cetuximab 250 mg/m\^2 infusions given over 60 minutes.
|
Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Magrolimab Priming Dose Only
Participants who received only the priming dose (1 mg/kg) of magrolimab in Phase 2 of the study.
|
|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter: AUClast of Magrolimab
Day 8 (Cycle 1 Day 8)
|
—
|
676 day*μg/mL
Standard Deviation 75.3
|
1530 day*μg/mL
Standard Deviation 513
|
2140 day*μg/mL
Standard Deviation 726
|
2920 day*μg/mL
Standard Deviation 600
|
1930 day*μg/mL
|
—
|
—
|
—
|
|
PK Parameter: AUClast of Magrolimab
Day 29 (Cycle 2 Day 1)
|
1420 day*μg/mL
Standard Deviation 711
|
1560 day*μg/mL
Standard Deviation 413
|
3330 day*μg/mL
Standard Deviation 1270
|
4480 day*μg/mL
Standard Deviation 1220
|
7340 day*μg/mL
Standard Deviation 2380
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-magrolimab dose (within 12 hours) and 1-hour post-magrolimab dose (infusion duration = approximately 3 hours on Day 1 and 2 hours on other days) on Days 8 (Cycle 1 Day 8) and 29 (Cycle 2 Day 1) (1 cycle = 4 weeks)Population: Participants in the PK Analysis Set with available data were analyzed.
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Outcome measures
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2
n=4 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2
n=3 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2
n=7 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
n=6 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
n=4 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1.After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 1 Safety Run-in: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
n=1 Participants
Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) in combination with cetuximab 250 mg/m\^2 infusions given over 60 minutes.
|
Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Magrolimab Priming Dose Only
Participants who received only the priming dose (1 mg/kg) of magrolimab in Phase 2 of the study.
|
|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter: AUCtau of Magrolimab
Day 8 (Cycle 1 Day 8)
|
—
|
676 day*μg/mL
Standard Deviation 75.3
|
1630 day*μg/mL
Standard Deviation 649
|
2140 day*μg/mL
Standard Deviation 726
|
—
|
1930 day*μg/mL
|
—
|
—
|
—
|
|
PK Parameter: AUCtau of Magrolimab
Day 29 (Cycle 2 Day 1)
|
1640 day*μg/mL
Standard Deviation 604
|
1560 day*μg/mL
Standard Deviation 413
|
3630 day*μg/mL
Standard Deviation 1040
|
4480 day*μg/mL
Standard Deviation 1220
|
8770 day*μg/mL
Standard Deviation 1120
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; post-treatment (assessed continuously up to 30 days after last dose; maximum 15.3 months )Population: Immunogenicity Analysis Set included participants with at least one reported ADA result.
Percentage of Participants With Positive ADA at any timepoint was reported.
Outcome measures
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2
n=6 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2
n=3 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2
n=10 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
n=7 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
n=6 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1.After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 1 Safety Run-in: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
n=16 Participants
Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) in combination with cetuximab 250 mg/m\^2 infusions given over 60 minutes.
|
Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
n=15 Participants
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
n=15 Participants
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Magrolimab Priming Dose Only
Participants who received only the priming dose (1 mg/kg) of magrolimab in Phase 2 of the study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Anti-drug Antibodies (ADA)
Baseline ADA
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
14.3 percentage of participants
|
0.00 percentage of participants
|
6.3 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
—
|
|
Percentage of Participants With Anti-drug Antibodies (ADA)
Post-Treatment ADA
|
33.3 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
6.3 percentage of participants
|
13.3 percentage of participants
|
0.00 percentage of participants
|
—
|
|
Percentage of Participants With Anti-drug Antibodies (ADA)
Overall ADA
|
33.3 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
14.3 percentage of participants
|
0.00 percentage of participants
|
12.5 percentage of participants
|
13.3 percentage of participants
|
0.00 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From Screening until 38.89 months (assessed on Cycle 3 Day 1 then every 8 weeks from Cycle 5 onwards up to 38.89 months; 1 cycle = 4 weeks)Population: Participants in All Treated with available data were analyzed. Efficacy results were planned to be reported separately for all CRC participants with KRASwt and KRASm tumors.
DCR was defined as the percentage of participants with disease control which consisted of CR+PR+SD. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters measured while on study. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2
n=32 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2
n=42 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1.After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 1 Safety Run-in: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) in combination with cetuximab 250 mg/m\^2 infusions given over 60 minutes.
|
Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Magrolimab Priming Dose Only
Participants who received only the priming dose (1 mg/kg) of magrolimab in Phase 2 of the study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Disease Control Rate (DCR) as Assessed by RECIST v1.1
|
50.0 percentage of participants
Interval 31.9 to 68.1
|
38.1 percentage of participants
Interval 23.6 to 54.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first objective response until documented PD (assessed on Cycle 3 Day 1 then every 8 weeks from Cycle 5 onwards up to 38.89 months; 1 cycle = 4 weeks)Population: Participants in All Treated with available data were analyzed. Efficacy results were planned to be reported separately for all CRC participants with KRASwt and KRASm tumors.
DOR was measured from when the first (objective) response was met (i.e., CR or PR) until the first date of objectively documented PD. Participants who did not have objectively PD was censored at their last documented progression-free date. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. Kaplan Meier estimate was used for analysis.
Outcome measures
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2
n=2 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1.After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 1 Safety Run-in: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) in combination with cetuximab 250 mg/m\^2 infusions given over 60 minutes.
|
Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Magrolimab Priming Dose Only
Participants who received only the priming dose (1 mg/kg) of magrolimab in Phase 2 of the study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR) as Assessed by RECIST v1.1
|
9.7 months
Interval 7.0 to 12.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose until documented PD/death (assessed on Cycle 3 Day 1 then every 8 weeks from Cycle 5 onwards up to 38.89 months; 1 cycle = 4 weeks)Population: Participants in All Treated with available data were analyzed. Efficacy results were planned to be reported separately for all CRC participants with KRASwt and KRASm tumors.
PFS was measured from first dose until the first date of objectively documented PD or death. Participants who did not have objectively documented PD and not died was censored at their last documented progression-free date. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. Kaplan Meier estimate was used for analysis.
Outcome measures
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2
n=32 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2
n=42 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1.After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 1 Safety Run-in: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) in combination with cetuximab 250 mg/m\^2 infusions given over 60 minutes.
|
Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Magrolimab Priming Dose Only
Participants who received only the priming dose (1 mg/kg) of magrolimab in Phase 2 of the study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS) as Assessed by RECIST v1.1
|
3.6 months
Interval 1.8 to 5.4
|
1.9 months
Interval 1.8 to 3.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose until death (assessed on Cycle 3 Day 1 then every 8 weeks from Cycle 5 onwards up to 38.89 months; 1 cycle = 4 weeks)Population: Participants in All Treated with available data were analyzed. Efficacy results were planned to be reported separately for all CRC participants with KRASwt and KRASm tumors.
OS was measured from first dose until death. Participants who did not die were censored at their last known alive date. Kaplan Meier estimate was used for analysis.
Outcome measures
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2
n=32 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2
n=42 Participants
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1.After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 1 Safety Run-in: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) in combination with cetuximab 250 mg/m\^2 infusions given over 60 minutes.
|
Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m\^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m\^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
|
Magrolimab Priming Dose Only
Participants who received only the priming dose (1 mg/kg) of magrolimab in Phase 2 of the study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
9.5 months
Interval 5.9 to 12.6
|
7.6 months
Interval 5.4 to 11.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Magrolimab 10 mg/kg
Magrolimab 20 mg/kg
Magrolimab 30 mg/kg
Magrolimab 45 mg/kg
Magrolimab Priming Dose Only
Serious adverse events
| Measure |
Magrolimab 10 mg/kg
n=9 participants at risk
Participants who received magrolimab maintenance dose of 10 mg/kg in combination with cetuximab in any part of the study.
|
Magrolimab 20 mg/kg
n=10 participants at risk
Participants who received magrolimab maintenance dose of 20 mg/kg in combination with cetuximab in any part of the study.
|
Magrolimab 30 mg/kg
n=36 participants at risk
Participants who received magrolimab maintenance dose of 30 mg/kg in combination with cetuximab in any part of the study.
|
Magrolimab 45 mg/kg
n=20 participants at risk
Participants who received magrolimab maintenance dose of 45 mg/kg in combination with cetuximab in any part of the study.
|
Magrolimab Priming Dose Only
n=3 participants at risk
Participants who received only the priming dose (1 mg/kg) of magrolimab in Phase 2 of the study.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
33.3%
1/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
22.2%
2/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
General disorders
Complication associated with device
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
General disorders
Pyrexia
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Infections and infestations
Cystitis
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
20.0%
2/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.6%
2/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
8.3%
3/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
33.3%
1/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Nervous system disorders
Cerebrovascular accident
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
Other adverse events
| Measure |
Magrolimab 10 mg/kg
n=9 participants at risk
Participants who received magrolimab maintenance dose of 10 mg/kg in combination with cetuximab in any part of the study.
|
Magrolimab 20 mg/kg
n=10 participants at risk
Participants who received magrolimab maintenance dose of 20 mg/kg in combination with cetuximab in any part of the study.
|
Magrolimab 30 mg/kg
n=36 participants at risk
Participants who received magrolimab maintenance dose of 30 mg/kg in combination with cetuximab in any part of the study.
|
Magrolimab 45 mg/kg
n=20 participants at risk
Participants who received magrolimab maintenance dose of 45 mg/kg in combination with cetuximab in any part of the study.
|
Magrolimab Priming Dose Only
n=3 participants at risk
Participants who received only the priming dose (1 mg/kg) of magrolimab in Phase 2 of the study.
|
|---|---|---|---|---|---|
|
Infections and infestations
Herpes zoster
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Infections and infestations
Lung infection
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Infections and infestations
Nail infection
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.6%
2/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Infections and infestations
Paronychia
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.6%
2/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Infections and infestations
Sinusitis
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
30.6%
11/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
20.0%
4/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Cardiac disorders
Palpitations
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
33.3%
1/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Ear and labyrinth disorders
Tinnitus
|
22.2%
2/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Eye disorders
Blepharal pigmentation
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Eye disorders
Conjunctivitis allergic
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Eye disorders
Dry eye
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Eye disorders
Photopsia
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
20.0%
2/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.6%
2/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Eye disorders
Strabismus
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Eye disorders
Vision blurred
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
8.3%
3/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
8.3%
3/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Gastrointestinal disorders
Abdominal distension
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
30.0%
3/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
11.1%
4/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
3/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
30.0%
3/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
16.7%
6/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
2/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
66.7%
2/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
8.3%
3/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
50.0%
5/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
16.7%
6/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
30.0%
6/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Gastrointestinal disorders
Diarrhoea
|
44.4%
4/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
30.0%
3/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
25.0%
9/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
35.0%
7/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
33.3%
1/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.6%
2/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
33.3%
1/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Gastrointestinal disorders
Loose tooth
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Gastrointestinal disorders
Nausea
|
22.2%
2/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
20.0%
2/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
44.4%
16/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
15.0%
3/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
33.3%
1/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Gastrointestinal disorders
Oesophageal pain
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Gastrointestinal disorders
Rectal discharge
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.6%
2/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
20.0%
2/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
22.2%
8/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
30.0%
6/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
30.0%
3/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
30.6%
11/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
20.0%
4/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
33.3%
1/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
General disorders
Chest discomfort
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
General disorders
Chest pain
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
General disorders
Chills
|
22.2%
2/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
20.0%
2/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
30.6%
11/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
25.0%
5/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
General disorders
Early satiety
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
General disorders
Fatigue
|
44.4%
4/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
50.0%
5/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
50.0%
18/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
35.0%
7/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
General disorders
Gait disturbance
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
33.3%
1/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
General disorders
Influenza like illness
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
8.3%
3/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
General disorders
Oedema
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
General disorders
Oedema peripheral
|
22.2%
2/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.6%
2/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
2/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
General disorders
Pain
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
8.3%
3/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
33.3%
1/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
General disorders
Performance status decreased
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
33.3%
1/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
General disorders
Pyrexia
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
20.0%
2/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
36.1%
13/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
40.0%
8/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
33.3%
1/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.6%
2/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Infections and infestations
Conjunctivitis
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Infections and infestations
Cystitis
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Infections and infestations
Folliculitis
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Infections and infestations
Gastroenteritis viral
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Infections and infestations
Skin infection
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Infections and infestations
Tinea cruris
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
20.0%
2/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
33.3%
3/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
30.0%
3/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
33.3%
12/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
35.0%
7/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
33.3%
1/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
20.0%
2/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
11.1%
4/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
20.0%
2/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
13.9%
5/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
33.3%
1/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
20.0%
2/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.6%
2/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
33.3%
1/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Investigations
Blood bilirubin increased
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
30.0%
3/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
13.9%
5/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
25.0%
5/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
33.3%
1/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
33.3%
1/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Investigations
Lymphocyte count decreased
|
44.4%
4/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
8.3%
3/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
15.0%
3/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Investigations
Platelet count decreased
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Investigations
Weight decreased
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
20.0%
2/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
8.3%
3/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
22.2%
2/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
30.0%
3/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
25.0%
9/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
25.0%
5/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Metabolism and nutrition disorders
Dehydration
|
22.2%
2/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
20.0%
2/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
11.1%
4/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
15.0%
3/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
20.0%
2/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
13.9%
5/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
20.0%
4/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
40.0%
4/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
27.8%
10/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
25.0%
5/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
33.3%
1/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
2/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.2%
2/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
20.0%
2/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
13.9%
5/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
11.1%
4/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
8.3%
3/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
22.2%
2/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
8.3%
3/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
20.0%
2/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
2/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
8.3%
3/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
2/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.6%
2/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Nervous system disorders
Headache
|
22.2%
2/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
20.0%
2/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
47.2%
17/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
40.0%
8/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
33.3%
1/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Nervous system disorders
Somnolence
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Nervous system disorders
Syncope
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Nervous system disorders
Tremor
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.6%
2/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Psychiatric disorders
Confusional state
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Psychiatric disorders
Depression
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
20.0%
4/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.6%
2/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
15.0%
3/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
33.3%
1/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.6%
2/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Renal and urinary disorders
Haematuria
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.6%
2/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
2/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.6%
2/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
33.3%
1/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
13.9%
5/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
20.0%
4/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.6%
2/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
30.6%
11/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
15.0%
3/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.6%
2/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.6%
2/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.6%
2/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.6%
2/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
2/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.6%
2/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
44.4%
4/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
50.0%
5/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
38.9%
14/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
30.0%
6/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
66.7%
6/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
30.0%
3/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
22.2%
8/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
50.0%
10/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
33.3%
1/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.6%
2/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
22.2%
2/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
19.4%
7/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
2/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
1/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
19.4%
7/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
2/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
22.2%
2/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
30.0%
3/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
19.4%
7/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
25.0%
5/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
33.3%
1/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
8.3%
3/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
11.1%
4/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Vascular disorders
Deep vein thrombosis
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Vascular disorders
Flushing
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
2.8%
1/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
10.0%
2/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Vascular disorders
Hypotension
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.6%
2/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
33.3%
1/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
0/9 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/10 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/36 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
5.0%
1/20 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
0.00%
0/3 • Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER