Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs
Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer · Source last updated 2026-09-09
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Day 1 through 21.4 months (maximum observed duration)
What was measured
Participants with abnormal laboratory parameters reported as TEAEs are reported. Laboratory analysis included hematology and clinical chemistry. TEAEs included events from the first dose of study drug, up to 90 days after the last dose of study drug received or up to the start date of any subsequent anticancer therapy following discontinuation of study drug, or the final safety DCO date of 01Sep2022, whichever occurred first.
Analysis population: The Safety Analysis Set included all participants randomized at least 2 months before the DCO 01Sep2022 (i.e. on or before 01Jul2022).
Groups in this outcome
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
Participants received IV monalizumab 750 mg Q2W and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Placebo Q2W + Cetuximab 400 mg/m^2
Participants receieved IV placebo matched to monalizumab Q2W and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
246
Placebo Q2W + Cetuximab 400 mg/m^2
122
Reported measurements
Anaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
35
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
15
Not reported
Not reported
Not reported
Not reported
Anaemia folate deficiency
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Hypochromic anaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Iron deficiency anaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Leukocytosis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
3
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
2
Not reported
Not reported
Not reported
Not reported
Leukopenia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Lymphocytosis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Lymphopenia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
3
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Neutropenia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Neutrophilia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
2
Not reported
Not reported
Not reported
Not reported
Normocytic anaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Thrombocytopenia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Thrombocytosis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
2
Not reported
Not reported
Not reported
Not reported
Hyperthyroidism
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Hypoparathyroidism
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Hypothyroidism
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
15
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
7
Not reported
Not reported
Not reported
Not reported
Hyperamylasaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Hypercalcaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
7
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
4
Not reported
Not reported
Not reported
Not reported
Hyperglycaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
7
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
5
Not reported
Not reported
Not reported
Not reported
Hyperkalaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
3
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Hyperlipasaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Hypermagnesaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
3
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Hyperphosphataemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Hypoalbuminaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
2
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
4
Not reported
Not reported
Not reported
Not reported
Hypocalcaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
11
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
4
Not reported
Not reported
Not reported
Not reported
Hypoglycaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Hypokalaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
13
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
9
Not reported
Not reported
Not reported
Not reported
Hypomagnesaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
42
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
21
Not reported
Not reported
Not reported
Not reported
Hyponatraemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
6
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
3
Not reported
Not reported
Not reported
Not reported
Hypophosphataemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
9
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
8
Not reported
Not reported
Not reported
Not reported
Iron deficiency
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Activated partial thromboplastin time prolonged
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Alanine aminotransferase increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
7
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
5
Not reported
Not reported
Not reported
Not reported
Amylase increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
6
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
3
Not reported
Not reported
Not reported
Not reported
Aspartate aminotransferase increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
7
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
4
Not reported
Not reported
Not reported
Not reported
Blood alkaline phosphatase increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
7
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
3
Not reported
Not reported
Not reported
Not reported
Blood beta-D-glucan increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Blood bilirubin increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
3
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Blood creatine phosphokinase increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
2
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Blood creatinine increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
6
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
3
Not reported
Not reported
Not reported
Not reported
Blood iron decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Blood lactate dehydrogenase increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
3
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
3
Not reported
Not reported
Not reported
Not reported
Blood phosphorus decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Blood potassium decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Blood thyroid stimulating hormone abnormal
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Blood thyroid stimulating hormone increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
2
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
3
Not reported
Not reported
Not reported
Not reported
Blood urea increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
C-reactive protein increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
2
Not reported
Not reported
Not reported
Not reported
Gamma-glutamyltransferase increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
5
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Inflammatory marker increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
International normalised ratio increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Lipase increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
12
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
2
Not reported
Not reported
Not reported
Not reported
Lymphocyte count decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
3
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Neutrophil count decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
2
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
3
Not reported
Not reported
Not reported
Not reported
Neutrophil count increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Platelet count decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Platelet count increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Transaminases increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
White blood cell count decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
2
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
3
Not reported
Not reported
Not reported
Not reported
White blood cell count increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Dyslipidaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Placebo Q2W + Cetuximab 400 mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
35
group Id
OG001
value
15
title
Anaemia
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Anaemia folate deficiency
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Hypochromic anaemia
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Iron deficiency anaemia
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
2
title
Leukocytosis
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Leukopenia
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Lymphocytosis
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
1
title
Lymphopenia
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
title
Neutropenia
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
title
Neutrophilia
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Normocytic anaemia
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Thrombocytopenia
denoms
counts
group Id
OG000
value
246
group Id
OG001
value
122
units
Participants
description
Participants with abnormal laboratory parameters reported as TEAEs are reported. Laboratory analysis included hematology and clinical chemistry. TEAEs included events from the first dose of study drug, up to 90 days after the last dose of study drug received or up to the start date of any subsequent anticancer therapy following discontinuation of study drug, or the final safety DCO date of 01Sep2022, whichever occurred first.
groups
description
Participants received IV monalizumab 750 mg Q2W and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
id
OG000
title
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
description
Participants receieved IV placebo matched to monalizumab Q2W and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
id
OG001
title
Placebo Q2W + Cetuximab 400 mg/m^2
param Type
COUNT_OF_PARTICIPANTS
population Description
The Safety Analysis Set included all participants randomized at least 2 months before the DCO 01Sep2022 (i.e. on or before 01Jul2022).
reporting Status
POSTED
time Frame
Day 1 through 21.4 months (maximum observed duration)
title
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs
Triangle