Trial Outcomes & Findings for A Phase 2 Study to Evaluate the Efficacy and Safety of AMG531 in Aplastic Anemia (NCT NCT02094417)

NCT ID: NCT02094417

Last Updated: 2024-04-30

Results Overview

The proportion of subjects achieving a platelet response at Week 9, and two-sided 95% confidence interval will be calculated. Platelet response is defined as 1) achieving absolute platelet increase of ≥ 20x10\^9/L above baseline or 2) increase to ≥ 10x10\^9/L and by at least 100% from baseline.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

At week 9

Results posted on

2024-04-30

Participant Flow

Subjects were enrolled from 14 April 2014 through 28 November 2014 from two clinical centers (Seoul St. Mary's Hospital and Samsung Medical Center, Seoul, South Korea).

Participant milestones

Participant milestones
Measure	AMG531 (Dose 1) AMG531: 1 μg/kg, subcutaneous, once weekly	AMG531 (Dose 2) AMG531: 3 μg/kg, subcutaneous, once weekly	AMG531 (Dose 3) AMG531: 6 μg/kg, subcutaneous, once weekly	AMG531 (Dose 4) AMG531: 10 μg/kg, subcutaneous, once weekly
Overall Study STARTED	7	9	9	10
Overall Study COMPLETED	2	1	4	3
Overall Study NOT COMPLETED	5	8	5	7

Reasons for withdrawal

Reasons for withdrawal
Measure	AMG531 (Dose 1) AMG531: 1 μg/kg, subcutaneous, once weekly	AMG531 (Dose 2) AMG531: 3 μg/kg, subcutaneous, once weekly	AMG531 (Dose 3) AMG531: 6 μg/kg, subcutaneous, once weekly	AMG531 (Dose 4) AMG531: 10 μg/kg, subcutaneous, once weekly
Overall Study Adverse Event	0	0	0	1
Overall Study Eligibility criteria	0	1	0	0
Overall Study No responder	4	4	4	3
Overall Study Unable to conduct observations or assess	0	1	0	0
Overall Study Withdrawal by Subject	1	2	1	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AMG531 (Dose 1) n=7 Participants AMG531: 1 μg/kg, subcutaneous, once weekly	AMG531 (Dose 3) n=9 Participants AMG531: 3 μg/kg, subcutaneous, once weekly	AMG531 (Dose 2) n=9 Participants AMG531: 6 μg/kg, subcutaneous, once weekly	AMG531 (Dose 4) n=10 Participants AMG531: 10 μg/kg, subcutaneous, once weekly	Total n=35 Participants Total of all reporting groups
Age, Continuous	45.0 years n=7 Participants	51.0 years n=9 Participants	50.0 years n=9 Participants	51.5 years n=10 Participants	49.0 years n=35 Participants
Sex: Female, Male Female	2 Participants n=7 Participants	6 Participants n=9 Participants	4 Participants n=9 Participants	6 Participants n=10 Participants	18 Participants n=35 Participants
Sex: Female, Male Male	5 Participants n=7 Participants	3 Participants n=9 Participants	5 Participants n=9 Participants	4 Participants n=10 Participants	17 Participants n=35 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Baseline platelet count	7.5 cells 10^9/L STANDARD_DEVIATION 3.6 • n=7 Participants	9.9 cells 10^9/L STANDARD_DEVIATION 8.5 • n=9 Participants	10.7 cells 10^9/L STANDARD_DEVIATION 6.9 • n=9 Participants	9.8 cells 10^9/L STANDARD_DEVIATION 5.1 • n=10 Participants	9.6 cells 10^9/L STANDARD_DEVIATION 6.2 • n=35 Participants
Baseline hemoglobin concentration	6.73 g/dL STANDARD_DEVIATION 0.57 • n=4 Participants • There was no data.	6.63 g/dL STANDARD_DEVIATION 0.71 • n=7 Participants • There was no data.	5.95 g/dL STANDARD_DEVIATION 1.04 • n=4 Participants • There was no data.	6.50 g/dL STANDARD_DEVIATION 2.14 • n=6 Participants • There was no data.	6.48 g/dL STANDARD_DEVIATION 1.26 • n=21 Participants • There was no data.
Baseline neutrophil count	0.8902 cells 10^9/L STANDARD_DEVIATION 0.3606 • n=7 Participants	0.9611 cells 10^9/L STANDARD_DEVIATION 0.6784 • n=9 Participants	0.8756 cells 10^9/L STANDARD_DEVIATION 0.5000 • n=9 Participants	0.9215 cells 10^9/L STANDARD_DEVIATION 0.3836 • n=10 Participants	0.9136 cells 10^9/L STANDARD_DEVIATION 0.4797 • n=35 Participants

PRIMARY outcome

Timeframe: At week 9

Population: All efficacy analyses were carried out using the Per Protocol Set, which was defined as all enrolled subjects who received ≥6 times of the specified dose, with no major violation in the initial dose evaluation period. The Overall Number of Participants Analyzed is not consistent with numbers provided in the Participant Flow module because the Participant Flow module has been recorded based on the Full Analysis Set.

Outcome measures

Outcome measures
Measure	AMG531 (Dose 1) n=7 Participants AMG531: 1 μg/kg, subcutaneous, once weekly	AMG531 (Dose 2) n=7 Participants AMG531: 3 μg/kg, subcutaneous, once weekly	AMG531 (Dose 3) n=9 Participants AMG531: 6 μg/kg, subcutaneous, once weekly	AMG531 (Dose 4) n=10 Participants AMG531: 10 μg/kg, subcutaneous, once weekly
Proportion of Subjects Achieving a Platelet Response at Week 9	0 Participants	0 Participants	3 Participants	7 Participants

SECONDARY outcome

Timeframe: Initial dose evaluation period (Week 9), Week 12, Week 16, Week 24, Week 52, Week 104, and Week 156

The proportion of subjects with a platelet response in any time during the initial dose evaluation period, Week 1 through Week 12, Week 1 through Week 16, Week 1 through Week 24, Week 1 through Week 52, Week 1 through Week 104 and Week 1 through Week 156.

Outcome measures

Outcome measures
Measure	AMG531 (Dose 1) n=7 Participants AMG531: 1 μg/kg, subcutaneous, once weekly	AMG531 (Dose 2) n=7 Participants AMG531: 3 μg/kg, subcutaneous, once weekly	AMG531 (Dose 3) n=9 Participants AMG531: 6 μg/kg, subcutaneous, once weekly	AMG531 (Dose 4) n=10 Participants AMG531: 10 μg/kg, subcutaneous, once weekly
Proportion of Subjects Achieving a Platelet Response Week 1 - Week 156	6 Participants	5 Participants	8 Participants	10 Participants
Proportion of Subjects Achieving a Platelet Response Initial dose evaluation period	3 Participants	3 Participants	6 Participants	10 Participants
Proportion of Subjects Achieving a Platelet Response Week 1 - Week 12	4 Participants	4 Participants	7 Participants	10 Participants
Proportion of Subjects Achieving a Platelet Response Week 1 - Week 16	4 Participants	4 Participants	7 Participants	10 Participants
Proportion of Subjects Achieving a Platelet Response Week 1 - Week 24	6 Participants	4 Participants	8 Participants	10 Participants
Proportion of Subjects Achieving a Platelet Response Week 1 - Week 52	6 Participants	5 Participants	8 Participants	10 Participants
Proportion of Subjects Achieving a Platelet Response Week 1 - Week 104	6 Participants	5 Participants	8 Participants	10 Participants

SECONDARY outcome

Timeframe: Initial dose evaluation period (Week 9), Week 12, Week 16, Week 24, Week 52, Week 104, and Week 156

Population: With respcet to platelet transfusion indendpendence, the proportion will be calculated based on all subjcets in each analysis set and all subjects receving platelet transfusion as a pretreatment 8 weeks prior to the first AMG531 administration respectively.

The proportion of subjects achieving platelet transfusion independency in any time during the initial dose evaluation period , Week 1 through Week 12, Week 1 through Week 16, Week 1 through Week 24, Week 1 through Week 52, Week 1 through Week 104, and Week1 through Week 156 will be calculated in the same manner as the primary variables (The number of subjects discontinued or subjects who have missing data will not be calculated). Platelet transfusion independence is defined as achieving transfusion free period of at least 8 consecutive weeks (56 days).

Outcome measures

Outcome measures
Measure	AMG531 (Dose 1) n=7 Participants AMG531: 1 μg/kg, subcutaneous, once weekly	AMG531 (Dose 2) n=7 Participants AMG531: 3 μg/kg, subcutaneous, once weekly	AMG531 (Dose 3) n=9 Participants AMG531: 6 μg/kg, subcutaneous, once weekly	AMG531 (Dose 4) n=10 Participants AMG531: 10 μg/kg, subcutaneous, once weekly
Proportion of Subjects Achieving Platelet Transfusion Independency Subjects with TF : Week 1 - Week 12	0 Participants	2 Participants	1 Participants	4 Participants
Proportion of Subjects Achieving Platelet Transfusion Independency All subjects : Initial dose evaluation period	0 Participants	2 Participants	0 Participants	2 Participants
Proportion of Subjects Achieving Platelet Transfusion Independency All subjects : Week 1 - Week 12	0 Participants	2 Participants	1 Participants	4 Participants
Proportion of Subjects Achieving Platelet Transfusion Independency All subjects : Week 1 - Week 16	0 Participants	2 Participants	2 Participants	4 Participants
Proportion of Subjects Achieving Platelet Transfusion Independency All subjects : Week 1 - Week 24	1 Participants	2 Participants	3 Participants	6 Participants
Proportion of Subjects Achieving Platelet Transfusion Independency All subjects : Week 1 - Week 52	2 Participants	2 Participants	3 Participants	6 Participants
Proportion of Subjects Achieving Platelet Transfusion Independency All subjects : Week 1 - Week 104	2 Participants	2 Participants	3 Participants	6 Participants
Proportion of Subjects Achieving Platelet Transfusion Independency All subjects : Week 1 - Week 156	2 Participants	2 Participants	3 Participants	6 Participants
Proportion of Subjects Achieving Platelet Transfusion Independency Subjects with TF : Initial dose evaluation period	0 Participants	2 Participants	0 Participants	2 Participants
Proportion of Subjects Achieving Platelet Transfusion Independency Subjects with TF : Week 1 - Week 16	0 Participants	2 Participants	2 Participants	4 Participants
Proportion of Subjects Achieving Platelet Transfusion Independency Subjects with TF : Week 1 - Week 24	1 Participants	2 Participants	3 Participants	6 Participants
Proportion of Subjects Achieving Platelet Transfusion Independency Subjects with TF : Week 1 - Week 52	2 Participants	2 Participants	3 Participants	6 Participants
Proportion of Subjects Achieving Platelet Transfusion Independency Subjects with TF : Week 1 - Week 104	2 Participants	2 Participants	3 Participants	6 Participants
Proportion of Subjects Achieving Platelet Transfusion Independency Subjects with TF : Week 1 - Week 156	2 Participants	2 Participants	3 Participants	6 Participants

SECONDARY outcome

Timeframe: Initial dose evaluation period (Week 9), Week 12, Week 16, Week 24, Week 52, Week 104, and Week 156

The proportion of subjects with erythroid response, neutrophil response and erythroid and/or neutrophil response in any time during the initial dose evaluation period, Week 1 through Week 12, Week 1 through Week 16, Week 1 through Week 24, Week 1 through Week 52, Week 1 through Week 104, and Week1 through Week 156 will be calculated in the same manner as the primary variables (The number of subjects discontinued or subjects who have missing data will not be calculated).

Outcome measures

Outcome measures
Measure	AMG531 (Dose 1) n=7 Participants AMG531: 1 μg/kg, subcutaneous, once weekly	AMG531 (Dose 2) n=7 Participants AMG531: 3 μg/kg, subcutaneous, once weekly	AMG531 (Dose 3) n=9 Participants AMG531: 6 μg/kg, subcutaneous, once weekly	AMG531 (Dose 4) n=10 Participants AMG531: 10 μg/kg, subcutaneous, once weekly
Proportion of Subjects Achieving Erythroid Response and/or Neutrophil Response Neutrophil Response : Week 1 - Week 52	4 Participants	5 Participants	5 Participants	7 Participants
Proportion of Subjects Achieving Erythroid Response and/or Neutrophil Response Neutrophil Response : Week 1 - Week 104	4 Participants	5 Participants	5 Participants	7 Participants
Proportion of Subjects Achieving Erythroid Response and/or Neutrophil Response Neutrophil Response : Week 1 - Week 156	4 Participants	5 Participants	5 Participants	7 Participants
Proportion of Subjects Achieving Erythroid Response and/or Neutrophil Response Erythroid response and/or Neutrophil response : Initial dose evaluation period	1 Participants	4 Participants	5 Participants	7 Participants
Proportion of Subjects Achieving Erythroid Response and/or Neutrophil Response Erythroid response and/or Neutrophil response : Week 1 - Week 12	1 Participants	5 Participants	7 Participants	7 Participants
Proportion of Subjects Achieving Erythroid Response and/or Neutrophil Response Erythroid response and/or Neutrophil response : Week 1 - Week 16	4 Participants	5 Participants	7 Participants	7 Participants
Proportion of Subjects Achieving Erythroid Response and/or Neutrophil Response Erythroid response and/or Neutrophil response : Week 1 - Week 24	7 Participants	6 Participants	8 Participants	8 Participants
Proportion of Subjects Achieving Erythroid Response and/or Neutrophil Response Erythroid response and/or Neutrophil response : Week 1 - Week 52	7 Participants	6 Participants	8 Participants	8 Participants
Proportion of Subjects Achieving Erythroid Response and/or Neutrophil Response Erythroid response and/or Neutrophil response : Week 1 - Week 104	7 Participants	6 Participants	8 Participants	8 Participants
Proportion of Subjects Achieving Erythroid Response and/or Neutrophil Response Erythroid response and/or Neutrophil response : Week 1 - Week 156	7 Participants	6 Participants	8 Participants	8 Participants
Proportion of Subjects Achieving Erythroid Response and/or Neutrophil Response Neutrophil Response : Week 1 - Week 16	2 Participants	4 Participants	5 Participants	6 Participants
Proportion of Subjects Achieving Erythroid Response and/or Neutrophil Response Neutrophil Response : Week 1 - Week 24	4 Participants	4 Participants	5 Participants	7 Participants
Proportion of Subjects Achieving Erythroid Response and/or Neutrophil Response Erythroid Response : Initial dose evaluation period	0 Participants	2 Participants	1 Participants	3 Participants
Proportion of Subjects Achieving Erythroid Response and/or Neutrophil Response Erythroid Response : Week 1 - Week 12	0 Participants	4 Participants	4 Participants	4 Participants
Proportion of Subjects Achieving Erythroid Response and/or Neutrophil Response Erythroid Response : Week 1 - Week 16	3 Participants	4 Participants	4 Participants	4 Participants
Proportion of Subjects Achieving Erythroid Response and/or Neutrophil Response Erythroid Response : Week 1 - Week 24	5 Participants	5 Participants	7 Participants	5 Participants
Proportion of Subjects Achieving Erythroid Response and/or Neutrophil Response Erythroid Response : Week 1 - Week 52	6 Participants	5 Participants	7 Participants	7 Participants
Proportion of Subjects Achieving Erythroid Response and/or Neutrophil Response Erythroid Response : Week 1 - Week 104	6 Participants	5 Participants	7 Participants	7 Participants
Proportion of Subjects Achieving Erythroid Response and/or Neutrophil Response Erythroid Response : Week 1 - Week 156	6 Participants	5 Participants	7 Participants	7 Participants
Proportion of Subjects Achieving Erythroid Response and/or Neutrophil Response Neutrophil Response : Initial dose evaluation period	1 Participants	3 Participants	4 Participants	6 Participants
Proportion of Subjects Achieving Erythroid Response and/or Neutrophil Response Neutrophil Response : Week 1 - Week 12	1 Participants	3 Participants	5 Participants	6 Participants

SECONDARY outcome

Timeframe: Initial dose evaluation period (Week 9), Week 12, Week 16, Week 24, Week 52, Week 104, and Week 156

Population: A total of 29 subjects achieved a platelet response and the median duration of the platelet response was 77.0 days (range: 5 to 959 days). For the 29 subjects who achieved a platelet response, the median time to the initial platelet response was 43 days (range: 8 to 219 days).

For subjects with a platelet response in any time, time to the initial platelet response and duration of platelet response will be summarized Time to the initial platelet response will be calculated as sampling date (response achieved) minus first dose date of study drug plus 1. Duration of platelet response will be calculated as the maximum of the duration of platelet response for each subject, each duration of response calculated as the date when response is disappeared minus the date when response is achieved. The censoring date is defined as the date of the last Platelet examination or EOS whichever archives first.

Outcome measures

Outcome measures
Measure	AMG531 (Dose 1) n=7 Participants AMG531: 1 μg/kg, subcutaneous, once weekly	AMG531 (Dose 2) n=7 Participants AMG531: 3 μg/kg, subcutaneous, once weekly	AMG531 (Dose 3) n=9 Participants AMG531: 6 μg/kg, subcutaneous, once weekly	AMG531 (Dose 4) n=10 Participants AMG531: 10 μg/kg, subcutaneous, once weekly
Duration of Platelet Response and Time to Platelet Response Duration of platelet response	24.5 days Interval 14.0 to 506.0	21.0 days Interval 9.0 to 862.0	503.5 days Interval 7.0 to 959.0	131.0 days Interval 5.0 to 886.0
Duration of Platelet Response and Time to Platelet Response Time to the initial platelet response	59.0 days Interval 8.0 to 127.0	44.0 days Interval 15.0 to 219.0	53.5 days Interval 22.0 to 134.0	41.0 days Interval 36.0 to 50.0

SECONDARY outcome

Timeframe: Initial dose evaluation period (Week 9), Week 12, Week 16, Week 24, Week 52, Week 104, and Week 157

Tri-lineage response is defined in those achieving platelet response, erythroid response, and neutrophil response all together. The proportion of subjects with tri-lineage response will be calculated in the same manner as the primary variables. Time to tri-lineage response will be summarized in the same manner as time to platelet response. Time to tri-lineage response is defined as duration of the time from Day 1 to the date of platelet response, erythroid response or neutrophil response whichever achieves last in Visit.

Outcome measures

Outcome measures
Measure	AMG531 (Dose 1) n=7 Participants AMG531: 1 μg/kg, subcutaneous, once weekly	AMG531 (Dose 2) n=7 Participants AMG531: 3 μg/kg, subcutaneous, once weekly	AMG531 (Dose 3) n=9 Participants AMG531: 6 μg/kg, subcutaneous, once weekly	AMG531 (Dose 4) n=10 Participants AMG531: 10 μg/kg, subcutaneous, once weekly
Proportion of Subjects Achieving Tri-lineage Responses Week 9	0 Participants	0 Participants	0 Participants	0 Participants
Proportion of Subjects Achieving Tri-lineage Responses Week 13	0 Participants	0 Participants	0 Participants	0 Participants
Proportion of Subjects Achieving Tri-lineage Responses Week 17	0 Participants	1 Participants	0 Participants	0 Participants
Proportion of Subjects Achieving Tri-lineage Responses Week 25	1 Participants	1 Participants	1 Participants	1 Participants
Proportion of Subjects Achieving Tri-lineage Responses Week 27	0 Participants	1 Participants	2 Participants	0 Participants
Proportion of Subjects Achieving Tri-lineage Responses Week 53	1 Participants	1 Participants	2 Participants	1 Participants
Proportion of Subjects Achieving Tri-lineage Responses Week 105	1 Participants	1 Participants	2 Participants	1 Participants
Proportion of Subjects Achieving Tri-lineage Responses Week 157	1 Participants	1 Participants	3 Participants	0 Participants

SECONDARY outcome

Timeframe: Initial dose evaluation period (Week 9), Week 12, Week 16, Week 24, Week 52, Week 104, and Week 156

Population: 3/33 (9.1%) subjects (who maintained blood cell response) discontinued the study drug during Week 1 to Week 156.

The longest duration of study drug discontinuation in subjects while maintaining a stable response is summarized

Outcome measures

Outcome measures
Measure	AMG531 (Dose 1) AMG531: 1 μg/kg, subcutaneous, once weekly	AMG531 (Dose 2) AMG531: 3 μg/kg, subcutaneous, once weekly	AMG531 (Dose 3) n=2 Participants AMG531: 6 μg/kg, subcutaneous, once weekly	AMG531 (Dose 4) n=1 Participants AMG531: 10 μg/kg, subcutaneous, once weekly
Duration of Study Drug Discontinuation While Maintaining Stable Response	—	—	273.0 days Interval 56.0 to 490.0	483.0 days Interval 483.0 to 483.0

Adverse Events

AMG531 (Dose 1)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

AMG531 (Dose 2)

Serious events: 2 serious events

Other events: 5 other events

Deaths: 1 deaths

AMG531 (Dose 3)

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

AMG531 (Dose 4)

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AMG531 (Dose 1) n=7 participants at risk AMG531: Subcutaneous, weekly injection	AMG531 (Dose 2) n=9 participants at risk AMG531: Subcutaneous, weekly injection	AMG531 (Dose 3) n=9 participants at risk AMG531: Subcutaneous, weekly injection	AMG531 (Dose 4) n=10 participants at risk AMG531: Subcutaneous, weekly injection
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/7 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.	11.1% 1/9 • Number of events 1 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.	0.00% 0/9 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.	0.00% 0/10 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.
Eye disorders Cataract	0.00% 0/7 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.	0.00% 0/9 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.	0.00% 0/9 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.	10.0% 1/10 • Number of events 1 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.
Eye disorders Retinal detachment	0.00% 0/7 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.	0.00% 0/9 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.	0.00% 0/9 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.	10.0% 1/10 • Number of events 1 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.
Eye disorders Macular fibrosis	0.00% 0/7 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.	0.00% 0/9 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.	11.1% 1/9 • Number of events 1 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.	0.00% 0/10 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.
Gastrointestinal disorders Inguinal hernia	0.00% 0/7 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.	0.00% 0/9 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.	0.00% 0/9 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.	10.0% 1/10 • Number of events 1 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.
Infections and infestations Appendicitis	0.00% 0/7 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.	0.00% 0/9 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.	11.1% 1/9 • Number of events 1 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.	0.00% 0/10 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.
Infections and infestations Cellulitis	0.00% 0/7 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.	11.1% 1/9 • Number of events 1 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.	0.00% 0/9 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.	0.00% 0/10 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.
Injury, poisoning and procedural complications Tendon injury	0.00% 0/7 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.	0.00% 0/9 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.	11.1% 1/9 • Number of events 1 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.	0.00% 0/10 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/7 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.	0.00% 0/9 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.	0.00% 0/9 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.	10.0% 1/10 • Number of events 1 • Up to 3 years This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.

Other adverse events

Additional Information

Clinical Development Team, Clinical Development Department

Kyowa Kirin Korea Co. Ltd.,

Phone: 82221912918

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place