NCT01849874 · OUTCOME

Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03

A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer · Source last updated 2023-10-30

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: From the first dose of study intervention until 30 days after the last dose (up to 9 years)

What was measured

Number of participants with shifts from normal Baseline values (Grade 0) to abnormal post-baseline values on-study (shift to greater than or equal to Grade 3) were reported as per NCI-CTCAE, v4.03 graded from Grade 1 to 5. Grade 1: Mild; asymptomatic/ mild symptoms; clinical/diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local/noninvasive intervention indicated. Grade 3: Severe/medically significant but not immediately life-threatening; hospitalization/prolongation of hospitalization indicated. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death. Shifts in lab parameter from Grade 0 to 3, Grade 0 to 4 and Grade 0 to Low 3 and 4 and Grade 0 to High 3 and 4 (for parameters total hemoglobin, lymphocytes, white blood cells, calcium, magnesium, potassium, and sodium) were reported.

Analysis population: The safety set included all participants who received at least 1 dose of study intervention and had at least 1 post-treatment assessment, including death. No data was collected for the crossover set due to the early stopping of the crossover period.

Groups in this outcome

MEK162

Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study intervention.

Physician's Choice

Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one of the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m\^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m\^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study intervention.

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
MEK162	227
Physician's Choice	106

Reported measurements

International Normalized Ratio: Grade 0 to 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

International Normalized Ratio: Grade 0 to 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

Neutrophils: Grade 0 to 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	3	Not reported	Not reported	Not reported	Not reported
Physician's Choice	7	Not reported	Not reported	Not reported	Not reported

Neutrophils: Grade 0 to 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice	1	Not reported	Not reported	Not reported	Not reported

Platelet Count: Grade 0 to 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

Platelet Count: Grade 0 to 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	1	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

Partial Thromboplastin Time: Grade 0 to 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	4	Not reported	Not reported	Not reported	Not reported
Physician's Choice	2	Not reported	Not reported	Not reported	Not reported

Partial Thromboplastin Time: Grade 0 to 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

Total Hemoglobin: Grade 0 to Low 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	10	Not reported	Not reported	Not reported	Not reported
Physician's Choice	2	Not reported	Not reported	Not reported	Not reported

Total Hemoglobin: Grade 0 to Low 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

Total Hemoglobin: Grade 0 to High 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

Total Hemoglobin: Grade 0 to High 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

Lymphocytes: Grade 0 to Low 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	8	Not reported	Not reported	Not reported	Not reported
Physician's Choice	3	Not reported	Not reported	Not reported	Not reported

Lymphocytes: Grade 0 to Low 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	1	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

Lymphocytes: Grade 0 to High 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

Lymphocytes: Grade 0 to High 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

White Blood Cells: Grade 0 to Low 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice	1	Not reported	Not reported	Not reported	Not reported

White Blood Cells: Grade 0 to Low 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice	1	Not reported	Not reported	Not reported	Not reported

White Blood Cells: Grade 0 to High 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

White Blood Cells: Grade 0 to High 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

Albumin: Grade 0 to 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	1	Not reported	Not reported	Not reported	Not reported
Physician's Choice	1	Not reported	Not reported	Not reported	Not reported

Albumin: Grade 0 to 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

Alkaline Phosphatase: Grade 0 to 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	4	Not reported	Not reported	Not reported	Not reported
Physician's Choice	1	Not reported	Not reported	Not reported	Not reported

Alkaline Phosphatase: Grade 0 to 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

Alanine Aminotransferase/Serum Glutamic-Pyruvic Transaminase: Grade 0 to 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	7	Not reported	Not reported	Not reported	Not reported
Physician's Choice	1	Not reported	Not reported	Not reported	Not reported

Alanine Aminotransferase/Serum Glutamic-Pyruvic Transaminase: Grade 0 to 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

Aspartate Aminotransferase/Serum Glutamic-Oxaloacetic Transaminase: Grade 0 to 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	7	Not reported	Not reported	Not reported	Not reported
Physician's Choice	1	Not reported	Not reported	Not reported	Not reported

Aspartate Aminotransferase/Serum Glutamic-Oxaloacetic Transaminase: Grade 0 to 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

Creatine Kinase: Grade 0 to 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	52	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

Creatine Kinase: Grade 0 to 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	12	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

Serum Creatinine: Grade 0 to 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	1	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

Serum Creatinine: Grade 0 to 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

Total Bilirubin: Grade 0 to 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	1	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

Total Bilirubin: Grade 0 to 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

Calcium: Grade 0 to Low 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice	1	Not reported	Not reported	Not reported	Not reported

Calcium: Grade 0 to Low 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	1	Not reported	Not reported	Not reported	Not reported
Physician's Choice	1	Not reported	Not reported	Not reported	Not reported

Calcium: Grade 0 to High 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	1	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

Calcium: Grade 0 to High 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

Magnesium: Grade 0 to Low 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	2	Not reported	Not reported	Not reported	Not reported
Physician's Choice	1	Not reported	Not reported	Not reported	Not reported

Magnesium: Grade 0 to Low 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

Magnesium: Grade 0 to High 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	1	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

Magnesium: Grade 0 to High 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

Potassium: Grade 0 to Low 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	10	Not reported	Not reported	Not reported	Not reported
Physician's Choice	4	Not reported	Not reported	Not reported	Not reported

Potassium: Grade 0 to Low 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

Potassium: Grade 0 to High 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	3	Not reported	Not reported	Not reported	Not reported
Physician's Choice	2	Not reported	Not reported	Not reported	Not reported

Potassium: Grade 0 to High 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

Sodium: Grade 0 to Low 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	5	Not reported	Not reported	Not reported	Not reported
Physician's Choice	2	Not reported	Not reported	Not reported	Not reported

Sodium: Grade 0 to Low 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	1	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

Sodium: Grade 0 to High 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	3	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

Sodium: Grade 0 to High 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEK162	1	Not reported	Not reported	Not reported	Not reported
Physician's Choice	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
International Normalized Ratio: Grade 0 to 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
International Normalized Ratio: Grade 0 to 4
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
7
title
Neutrophils: Grade 0 to 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Neutrophils: Grade 0 to 4
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Platelet Count: Grade 0 to 3
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Platelet Count: Grade 0 to 4
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
2
title
Partial Thromboplastin Time: Grade 0 to 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Partial Thromboplastin Time: Grade 0 to 4
categories
measurements
group Id
OG000
value
10
group Id
OG001
value
2
title
Total Hemoglobin: Grade 0 to Low 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Total Hemoglobin: Grade 0 to Low 4
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Total Hemoglobin: Grade 0 to High 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Total Hemoglobin: Grade 0 to High 4

denoms

counts
group Id
OG000
value
227
group Id
OG001
value
106
units
Participants

description

groups

description
Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study intervention.
id
OG000
title
MEK162
description
Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one of the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m\^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m\^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study intervention.
id
OG001
title
Physician's Choice

param Type

COUNT_OF_PARTICIPANTS

population Description

The safety set included all participants who received at least 1 dose of study intervention and had at least 1 post-treatment assessment, including death. No data was collected for the crossover set due to the early stopping of the crossover period.

reporting Status

POSTED

time Frame

From the first dose of study intervention until 30 days after the last dose (up to 9 years)

title

Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03

type

SECONDARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice