Trial Outcomes & Findings for AB-16B5 Combined With Docetaxel in Subjects With Metastatic Non-Small Cell Lung Cancer (EGIA-002) (NCT NCT04364620)
NCT ID: NCT04364620
Last Updated: 2025-04-06
Results Overview
Objective response rate (ORR) was defined as the percent of subjects documented to have a confirmed complete response (CR) or partial response (PR) as per RECIST 1.1 where Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Every 6 weeks until the date of objectively documented progression for up to 2 years.
Results posted on
2025-04-06
Participant Flow
Participant milestones
| Measure |
AB-16B5 12 mg/kg & Docetaxel 75 mg/m2
Subjects were treated in 21-day cycles with AB-16B5 at a dose of 12 mg/kg once weekly on Days 1, 8 and 15 combined with docetaxel at a dose of 75 mg/m2 on Day 1. Study treatment continued until there was evidence of disease progression, unacceptable toxicity, withdrawal of consent or the Investigator felt that further treatment was not in the subject's best interest, whichever occurred first.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
35
|
Reasons for withdrawal
| Measure |
AB-16B5 12 mg/kg & Docetaxel 75 mg/m2
Subjects were treated in 21-day cycles with AB-16B5 at a dose of 12 mg/kg once weekly on Days 1, 8 and 15 combined with docetaxel at a dose of 75 mg/m2 on Day 1. Study treatment continued until there was evidence of disease progression, unacceptable toxicity, withdrawal of consent or the Investigator felt that further treatment was not in the subject's best interest, whichever occurred first.
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|---|---|
|
Overall Study
Disease Progression
|
20
|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Physician Decision
|
4
|
|
Overall Study
Death
|
3
|
|
Overall Study
Other
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
AB-16B5 Combined With Docetaxel in Subjects With Metastatic Non-Small Cell Lung Cancer (EGIA-002)
Baseline characteristics by cohort
| Measure |
AB-16B5 12 mg/kg & Docetaxel 75 mg/m2
n=35 Participants
Subjects were treated in 21-day cycles with AB-16B5 at a dose of 12 mg/kg once weekly on Days 1, 8 and 15 combined with docetaxel at a dose of 75 mg/m2 on Day 1. Study treatment continued until there was evidence of disease progression, unacceptable toxicity, withdrawal of consent or the Investigator felt that further treatment was not in the subject's best interest, whichever occurred first.
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|---|---|
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Age, Continuous
|
63.1 years
STANDARD_DEVIATION 9.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
26 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
|
Histological Classification of NSCLC
Adenocarcinoma
|
28 Participants
n=5 Participants
|
|
Histological Classification of NSCLC
Squamous Cell Lung Cancer
|
6 Participants
n=5 Participants
|
|
Histological Classification of NSCLC
Adenosquamous
|
1 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Score
0
|
11 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Score
1
|
22 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Score
2
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 6 weeks until the date of objectively documented progression for up to 2 years.Population: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Objective Response Rate was the Clinical Activity Evaluable (CAE) population which included all subjects who received at least one dose of each study treatment drug (AB-16B5 and Docetaxel) and who had at least one on-study disease assessment (post-dose) or developed early progression and discontinued study treatment prior to the first planned on-study disease assessment.
Objective response rate (ORR) was defined as the percent of subjects documented to have a confirmed complete response (CR) or partial response (PR) as per RECIST 1.1 where Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions.
Outcome measures
| Measure |
AB-16B5 12 mg/kg & Docetaxel 75 mg/m2
n=35 Participants
Subjects were treated in 21-day cycles with AB-16B5 at a dose of 12 mg/kg once weekly on Days 1, 8 and 15 combined with docetaxel at a dose of 75 mg/m2 on Day 1. Study treatment continued until there was evidence of disease progression, unacceptable toxicity, withdrawal of consent or the Investigator felt that further treatment was not in the subject's best interest, whichever occurred first.
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|---|---|
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Objective Response Rate (ORR)
|
6 Participants
|
SECONDARY outcome
Timeframe: Every 6 weeks until the date of objectively documented progression for up to 2 years.Population: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Clinical Benefit Rate was the Clinical Activity Evaluable (CAE) population which included all subjects who received at least one dose of each study treatment drug (AB-16B5 and Docetaxel) and who had at least one on-study disease assessment (post-dose) or developed early progression and discontinued study treatment prior to the first planned on-study disease assessment.
Clinical benefit rate (CBR) was defined as the percentage of subjects with complete response (CR), partial response (PR) or stable disease (SD) as per RECIST 1.1 where Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Outcome measures
| Measure |
AB-16B5 12 mg/kg & Docetaxel 75 mg/m2
n=35 Participants
Subjects were treated in 21-day cycles with AB-16B5 at a dose of 12 mg/kg once weekly on Days 1, 8 and 15 combined with docetaxel at a dose of 75 mg/m2 on Day 1. Study treatment continued until there was evidence of disease progression, unacceptable toxicity, withdrawal of consent or the Investigator felt that further treatment was not in the subject's best interest, whichever occurred first.
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|---|---|
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Clinical Benefit Rate (CBR)
|
16 Participants
|
SECONDARY outcome
Timeframe: Every 6 weeks until the date of objectively documented progression for up to 2 years.Population: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Duration of Response was the subjects achieving a confirmed CR or PR and who received at least one dose of each study treatment drug (AB-16B5 and Docetaxel).
Duration of response (DOR) was defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of objective progression of disease (PD) as per RECIST 1.1 or to death due to any cause in the absence of documented PD. DOR was calculated only for the subjects achieving a confirmed CR or PR. As per RECIST 1.1, Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions, or the appearance of one or more new lesions.
Outcome measures
| Measure |
AB-16B5 12 mg/kg & Docetaxel 75 mg/m2
n=6 Participants
Subjects were treated in 21-day cycles with AB-16B5 at a dose of 12 mg/kg once weekly on Days 1, 8 and 15 combined with docetaxel at a dose of 75 mg/m2 on Day 1. Study treatment continued until there was evidence of disease progression, unacceptable toxicity, withdrawal of consent or the Investigator felt that further treatment was not in the subject's best interest, whichever occurred first.
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|---|---|
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Duration of Response (DOR)
|
283.50 Days
Interval 81.0 to 548.0
|
SECONDARY outcome
Timeframe: Every 6 weeks until the date of objectively documented progression for up to 2 years.Population: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Duration of Clinical Benefit was the subjects achieving a clinical benefit (either CR, PR or SD) and who received at least one dose of each study treatment drug (AB-16B5 and Docetaxel).
Duration of clinical benefit (CB) was defined as the time from date of the first documentation of clinical benefit (either CR, PR or SD) to the first documentation of objective progression of disease (PD) as per RECIST 1.1 or to death due to any cause in the absence of documented PD. Duration of clinical benefit was calculated only for the subjects achieving a clinical benefit. As per RECIST 1.1, Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions, or the appearance of one or more new lesions.
Outcome measures
| Measure |
AB-16B5 12 mg/kg & Docetaxel 75 mg/m2
n=16 Participants
Subjects were treated in 21-day cycles with AB-16B5 at a dose of 12 mg/kg once weekly on Days 1, 8 and 15 combined with docetaxel at a dose of 75 mg/m2 on Day 1. Study treatment continued until there was evidence of disease progression, unacceptable toxicity, withdrawal of consent or the Investigator felt that further treatment was not in the subject's best interest, whichever occurred first.
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|---|---|
|
Duration of Clinical Benefit
|
230.00 Days
Interval 108.0 to 447.0
|
SECONDARY outcome
Timeframe: Every 6 weeks until the date of objectively documented progression for up to 2 years.Population: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Duration of Stable Disease was the subjects achieving a stable disease as their best overall response and who received at least one dose of each study treatment drug (AB-16B5 and Docetaxel).
Duration of stable disease (SD) was defined as the time from the date of the first study treatment to the first documentation of objective progression of disease (PD) as per RECIST 1.1 or to death due to any cause in the absence of documented PD. Duration of stable disease was calculated only for the subjects achieving a stable disease as their best overall response. The best overall response was defined as the best response recorded from the start of the study treatment until the end of study. As per RECIST 1.1, Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions, or the appearance of one or more new lesions.
Outcome measures
| Measure |
AB-16B5 12 mg/kg & Docetaxel 75 mg/m2
n=10 Participants
Subjects were treated in 21-day cycles with AB-16B5 at a dose of 12 mg/kg once weekly on Days 1, 8 and 15 combined with docetaxel at a dose of 75 mg/m2 on Day 1. Study treatment continued until there was evidence of disease progression, unacceptable toxicity, withdrawal of consent or the Investigator felt that further treatment was not in the subject's best interest, whichever occurred first.
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|---|---|
|
Duration of Stable Disease
|
255.00 Days
Interval 128.0 to 543.0
|
SECONDARY outcome
Timeframe: Every 6 weeks until the date of objectively documented progression for up to 2 years.Population: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint of Progression-free Survival was the modified Intent-to-Treat (mITT) population which included subjects who received at least one dose of each study treatment (AB-16B5 and Docetaxel).
Progression-free survival (PFS) was defined as the time from the date of first study treatment to the first documentation of objective progression of disease (PD) as per RECIST 1.1 or to death due to any cause in the absence of documented PD. For subjects who remained alive without progression at the end of the study, the event date was censored at the date of last disease assessment. As per RECIST 1.1, Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions, or the appearance of one or more new lesions.
Outcome measures
| Measure |
AB-16B5 12 mg/kg & Docetaxel 75 mg/m2
n=35 Participants
Subjects were treated in 21-day cycles with AB-16B5 at a dose of 12 mg/kg once weekly on Days 1, 8 and 15 combined with docetaxel at a dose of 75 mg/m2 on Day 1. Study treatment continued until there was evidence of disease progression, unacceptable toxicity, withdrawal of consent or the Investigator felt that further treatment was not in the subject's best interest, whichever occurred first.
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|---|---|
|
Progression Free Survival (PFS)
|
118.00 Days
Interval 47.0 to 231.0
|
SECONDARY outcome
Timeframe: From the start of study treatment up to the date of death or date of last contact for up to 3 years.Population: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Overall Survival was the modified Intent-to-Treat (mITT) population which included subjects who received at least one dose of each study treatment (AB-16B5 and Docetaxel).
Overall survival (OS) was defined as the time from date of first study treatment to death due to any cause. For surviving subjects at the end of the study, the OS endpoint was censored at the date of last contact (or last date known to be alive).
Outcome measures
| Measure |
AB-16B5 12 mg/kg & Docetaxel 75 mg/m2
n=35 Participants
Subjects were treated in 21-day cycles with AB-16B5 at a dose of 12 mg/kg once weekly on Days 1, 8 and 15 combined with docetaxel at a dose of 75 mg/m2 on Day 1. Study treatment continued until there was evidence of disease progression, unacceptable toxicity, withdrawal of consent or the Investigator felt that further treatment was not in the subject's best interest, whichever occurred first.
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|---|---|
|
Overall Survival (OS)
|
234.00 Days
Interval 148.0 to 437.0
|
Adverse Events
AB-16B5 12 mg/kg & Docetaxel 75 mg/m2
Serious events: 23 serious events
Other events: 35 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
AB-16B5 12 mg/kg & Docetaxel 75 mg/m2
n=35 participants at risk
Subjects were treated in 21-day cycles with AB-16B5 at a dose of 12 mg/kg once weekly on Days 1, 8 and 15 combined with docetaxel at a dose of 75 mg/m2 on Day 1. Study treatment continued until there was evidence of disease progression, unacceptable toxicity, withdrawal of consent or the Investigator felt that further treatment was not in the subject's best interest, whichever occurred first.
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|---|---|
|
Infections and infestations
Pneumonia
|
20.0%
7/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Infections and infestations
Diverticulitis
|
5.7%
2/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Infections and infestations
COVID-19
|
2.9%
1/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
2.9%
1/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Infections and infestations
Diverticulitis intestinal perforated
|
2.9%
1/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Infections and infestations
Groin infection
|
2.9%
1/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Infections and infestations
Influenza
|
2.9%
1/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Infections and infestations
Sepsis
|
2.9%
1/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Infections and infestations
Skin infection
|
2.9%
1/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Infections and infestations
Urosepsis
|
2.9%
1/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.7%
2/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
5.7%
2/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.7%
2/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.9%
1/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.9%
1/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.9%
1/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Vascular disorders
Hypotension
|
8.6%
3/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Vascular disorders
Capillary leak syndrome
|
2.9%
1/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
2.9%
1/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
2.9%
1/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
General disorders
Disease progression
|
5.7%
2/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
General disorders
Non-cardiac chest pain
|
2.9%
1/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
General disorders
Pyrexia
|
2.9%
1/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
General disorders
Vascular stent thrombosis
|
2.9%
1/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.7%
2/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Cardiac disorders
Angina pectoris
|
2.9%
1/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
2.9%
1/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
2.9%
1/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Injury, poisoning and procedural complications
Stoma site haemorrhage
|
2.9%
1/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Eye disorders
Retinopathy
|
2.9%
1/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.9%
1/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Nervous system disorders
Ischaemic stroke
|
2.9%
1/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Psychiatric disorders
Mental status changes
|
2.9%
1/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.9%
1/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
Other adverse events
| Measure |
AB-16B5 12 mg/kg & Docetaxel 75 mg/m2
n=35 participants at risk
Subjects were treated in 21-day cycles with AB-16B5 at a dose of 12 mg/kg once weekly on Days 1, 8 and 15 combined with docetaxel at a dose of 75 mg/m2 on Day 1. Study treatment continued until there was evidence of disease progression, unacceptable toxicity, withdrawal of consent or the Investigator felt that further treatment was not in the subject's best interest, whichever occurred first.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
45.7%
16/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
37.1%
13/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
8.6%
3/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.4%
4/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
5.7%
2/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Cardiac disorders
Tachycardia
|
14.3%
5/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
8.6%
3/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Endocrine disorders
Hypothyroidism
|
5.7%
2/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Eye disorders
Conjunctival haemorrhage
|
5.7%
2/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Eye disorders
Lacrimation increased
|
14.3%
5/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
7/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Gastrointestinal disorders
Constipation
|
22.9%
8/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
45.7%
16/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.6%
3/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
8.6%
3/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Gastrointestinal disorders
Nausea
|
48.6%
17/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
5.7%
2/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
20.0%
7/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
10/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
General disorders
Chest pain
|
8.6%
3/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
General disorders
Chills
|
11.4%
4/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
General disorders
Fatigue
|
82.9%
29/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
General disorders
Infusion site extravasation
|
5.7%
2/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
General disorders
Injection site reaction
|
22.9%
8/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
General disorders
Oedema
|
8.6%
3/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
General disorders
Oedema peripheral
|
31.4%
11/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
General disorders
Pain
|
8.6%
3/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
General disorders
Pyrexia
|
34.3%
12/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Infections and infestations
COVID-19
|
8.6%
3/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Infections and infestations
Oral candidiasis
|
17.1%
6/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Infections and infestations
Pneumonia
|
17.1%
6/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Infections and infestations
Skin infection
|
11.4%
4/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Infections and infestations
Urinary tract infection
|
11.4%
4/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
8.6%
3/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
45.7%
16/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Investigations
Alanine aminotransferase increased
|
5.7%
2/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.7%
2/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Investigations
Weight decreased
|
22.9%
8/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Investigations
Weight increased
|
5.7%
2/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
34.3%
12/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.7%
2/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
17.1%
6/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.7%
9/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
31.4%
11/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.7%
2/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
14.3%
5/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.9%
8/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
7/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
11.4%
4/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.7%
2/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.6%
3/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.7%
9/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.7%
2/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.4%
4/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Nervous system disorders
Dizziness
|
17.1%
6/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Nervous system disorders
Dysgeusia
|
17.1%
6/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Nervous system disorders
Headache
|
25.7%
9/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
17.1%
6/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Nervous system disorders
Paraesthesia
|
17.1%
6/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Nervous system disorders
Somnolence
|
11.4%
4/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Psychiatric disorders
Anxiety
|
8.6%
3/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Psychiatric disorders
Confusional state
|
8.6%
3/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Psychiatric disorders
Insomnia
|
25.7%
9/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Renal and urinary disorders
Haematuria
|
5.7%
2/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
8.6%
3/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.7%
9/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
54.3%
19/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.6%
3/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.6%
3/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.7%
2/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.7%
2/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
17.1%
6/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.6%
3/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.7%
2/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.7%
2/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.7%
2/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
71.4%
25/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.4%
4/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
17.1%
6/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.7%
2/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
8.6%
3/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
5.7%
2/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.6%
3/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.6%
3/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Vascular disorders
Flushing
|
5.7%
2/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Vascular disorders
Haematoma
|
8.6%
3/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Vascular disorders
Hypotension
|
22.9%
8/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
|
Vascular disorders
Thrombophlebitis
|
5.7%
2/35 • For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up. Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
|
Additional Information
Dr. Julie Laurin, Vice-President, Drug Development
Alethia Biotherapeutics ULC
Phone: 514-581-8125
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place