Trial Outcomes & Findings for A Study to Assess the Pharmacokinetics of Ramucirumab (IMC-1121B) in Combination With FOLFIRI (NCT NCT01634555)
NCT ID: NCT01634555
Last Updated: 2019-02-26
Results Overview
Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
Cycle 1: 0, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 22, 25, 28, 31, 34, 48, 72, 96 and 168 hours post-irinotecan infusion
Results posted on
2019-02-26
Participant Flow
Participant milestones
| Measure |
Ramucirumab (IMC-1121B) and FOLFIRI
Treatment is sequential. Ramucirumab (IMC-1121B) was administered before FOLFIRI (Irinotecan + Folinic acid + 5-Fluorouracil) during Cycles 2+
Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered as an intravenous (IV) infusion on Day 1 of each 2-week cycle (except Cycle 1)
Irinotecan: 180 milligrams per square meter (mg/m²) administered IV on Day 1 of each 2-week cycle
Folinic acid: 400 mg/m² administered IV on Day 1 of each 2-week cycle
5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of each cycle, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of each 2-week cycle
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
29
|
|
Overall Study
Drug-Drug Interaction (DDI) Population
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Ramucirumab (IMC-1121B) and FOLFIRI
Treatment is sequential. Ramucirumab (IMC-1121B) was administered before FOLFIRI (Irinotecan + Folinic acid + 5-Fluorouracil) during Cycles 2+
Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered as an intravenous (IV) infusion on Day 1 of each 2-week cycle (except Cycle 1)
Irinotecan: 180 milligrams per square meter (mg/m²) administered IV on Day 1 of each 2-week cycle
Folinic acid: 400 mg/m² administered IV on Day 1 of each 2-week cycle
5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of each cycle, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of each 2-week cycle
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
A Study to Assess the Pharmacokinetics of Ramucirumab (IMC-1121B) in Combination With FOLFIRI
Baseline characteristics by cohort
| Measure |
Ramucirumab (IMC-1121B) and FOLFIRI
n=29 Participants
Treatment is sequential. Ramucirumab (IMC-1121B) was administered before FOLFIRI (Irinotecan + Folinic acid + 5-Fluorouracil) during Cycles 2+
Ramucirumab (IMC-1121B): 8 mg/kg administered as IV infusion on Day 1 of each 2-week cycle (except Cycle 1)
Irinotecan: 180 mg/m² administered IV on Day 1 of each 2-week cycle
Folinic acid: 400 mg/m² administered IV on Day 1 of each 2-week cycle
5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of each 2-week cycle, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of each cycle
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Cycle 1: 0, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 22, 25, 28, 31, 34, 48, 72, 96 and 168 hours post-irinotecan infusionPopulation: All participants in DDI population (who completed the required treatment in Cycle 1, Day 1 and Cycle 2, Day 1) and had sufficient concentration data to calculate irinotecan and its metabolite SN-38 AUC(0-∞) in Cycle 1.
Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.
Outcome measures
| Measure |
FOLFIRI (Cycle 1)
n=25 Participants
Irinotecan: 180 mg/m² administered IV on Day 1 of Cycle 1 (2-week cycle)
Folinic acid: 400 mg/m² administered IV on Day 1 of Cycle 1 (2-week cycle)
5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of Cycle 1 (2-week cycle)
|
|---|---|
|
Pharmacokinetics: Dose-Normalized Area Under the Concentration Versus Time Curve of Irinotecan and Its Metabolite SN-38 From Time Zero to Infinity [AUC(0-∞)] in Cycle 1
Irinotecan
|
22.12 nanograms*hour/milliliter/milligram
Interval 19.72 to 24.82
|
|
Pharmacokinetics: Dose-Normalized Area Under the Concentration Versus Time Curve of Irinotecan and Its Metabolite SN-38 From Time Zero to Infinity [AUC(0-∞)] in Cycle 1
Metabolite SN-38
|
0.81 nanograms*hour/milliliter/milligram
Interval 0.7 to 0.93
|
PRIMARY outcome
Timeframe: Cycle 2: 0, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 22, 25, 28, 31, 34, 48, 72, 96 and 168 hours post-irinotecan infusionPopulation: All participants in DDI population (who completed the required treatment in Cycle 1, Day 1 and Cycle 2, Day 1) and had sufficient concentration data to calculate irinotecan and its metabolite SN-38 AUC(0-∞) in Cycle 2.
Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geo LS means. Geo LS means were adjusted for cycle, participant and random error.
Outcome measures
| Measure |
FOLFIRI (Cycle 1)
n=25 Participants
Irinotecan: 180 mg/m² administered IV on Day 1 of Cycle 1 (2-week cycle)
Folinic acid: 400 mg/m² administered IV on Day 1 of Cycle 1 (2-week cycle)
5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of Cycle 1 (2-week cycle)
|
|---|---|
|
Pharmacokinetics: Dose-Normalized AUC(0-∞) of Irinotecan and Its Metabolite SN-38 in Cycle 2
Irinotecan
|
20.56 nanograms*hour/milliliter/milligram
Interval 18.33 to 23.06
|
|
Pharmacokinetics: Dose-Normalized AUC(0-∞) of Irinotecan and Its Metabolite SN-38 in Cycle 2
Metabolite SN-38
|
0.77 nanograms*hour/milliliter/milligram
Interval 0.67 to 0.89
|
PRIMARY outcome
Timeframe: Cycle 1: 0, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 22, 25, 28, 31, 34, 48, 72, 96 and 168 hours post-irinotecan infusionPopulation: All participants in DDI population (who completed the required treatment in Cycle 1, Day 1 and Cycle 2, Day 1) and had sufficient concentration data to calculate irinotecan and its metabolite SN-38 Cmax in Cycle 1.
Dose-normalized Cmax was calculated from Cmax divided by the dose. Data presented are Geo LS means. Geo LS means were adjusted for cycle, participant and random error.
Outcome measures
| Measure |
FOLFIRI (Cycle 1)
n=23 Participants
Irinotecan: 180 mg/m² administered IV on Day 1 of Cycle 1 (2-week cycle)
Folinic acid: 400 mg/m² administered IV on Day 1 of Cycle 1 (2-week cycle)
5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of Cycle 1 (2-week cycle)
|
|---|---|
|
Pharmacokinetics: Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Irinotecan and Its Metabolite SN-38 in Cycle 1
Irinotecan
|
3.18 nanograms/milliliter/milligram
Interval 2.91 to 3.48
|
|
Pharmacokinetics: Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Irinotecan and Its Metabolite SN-38 in Cycle 1
Metabolite SN-38
|
0.05 nanograms/milliliter/milligram
Interval 0.04 to 0.06
|
PRIMARY outcome
Timeframe: Cycle 2: 0, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 22, 25, 28, 31, 34, 48, 72, 96 and 168 hours post-irinotecan infusionPopulation: All participants in DDI population (who completed the required treatment in Cycle 1, Day 1 and Cycle 2, Day 1) and had sufficient concentration data to calculate irinotecan and its metabolite SN-38 Cmax in Cycle 2.
Dose-normalized Cmax was calculated from Cmax divided by the dose. Data presented are Geo LS means. Geo LS means were adjusted for cycle, participant and random error.
Outcome measures
| Measure |
FOLFIRI (Cycle 1)
n=23 Participants
Irinotecan: 180 mg/m² administered IV on Day 1 of Cycle 1 (2-week cycle)
Folinic acid: 400 mg/m² administered IV on Day 1 of Cycle 1 (2-week cycle)
5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of Cycle 1 (2-week cycle)
|
|---|---|
|
Pharmacokinetics: Dose-Normalized Cmax of Irinotecan and Its Metabolite SN-38 in Cycle 2
Metabolite SN-38
|
0.05 nanograms/milliliter/milligram
Interval 0.04 to 0.06
|
|
Pharmacokinetics: Dose-Normalized Cmax of Irinotecan and Its Metabolite SN-38 in Cycle 2
Irinotecan
|
3.31 nanograms/milliliter/milligram
Interval 3.02 to 3.62
|
SECONDARY outcome
Timeframe: Cycle 2: -2, -1, -0.5, 0, 2, 3, 4, 5, 8, 10, 25, 48, 72, 96, 168, 264, 336 hours post-ramucirumab (IMC-1121B) infusionPopulation: All participants who received study drug and had sufficient concentration data to calculate ramucirumab (IMC-1121B) Cmax in Cycle 2.
Outcome measures
| Measure |
FOLFIRI (Cycle 1)
n=25 Participants
Irinotecan: 180 mg/m² administered IV on Day 1 of Cycle 1 (2-week cycle)
Folinic acid: 400 mg/m² administered IV on Day 1 of Cycle 1 (2-week cycle)
5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of Cycle 1 (2-week cycle)
|
|---|---|
|
Pharmacokinetics: Cmax of Ramucirumab (IMC-1121B)
|
201.6 micrograms/milliliter (µg/mL)
Geometric Coefficient of Variation 31
|
SECONDARY outcome
Timeframe: Up To 2 YearsPopulation: All participants with both baseline and at least one post baseline ADA assessments.
Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group.
Outcome measures
| Measure |
FOLFIRI (Cycle 1)
n=11 Participants
Irinotecan: 180 mg/m² administered IV on Day 1 of Cycle 1 (2-week cycle)
Folinic acid: 400 mg/m² administered IV on Day 1 of Cycle 1 (2-week cycle)
5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of Cycle 1 (2-week cycle)
|
|---|---|
|
Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA)
|
0 Participants
|
Adverse Events
Ramucirumab (IMC-1121B) and FOLFIRI
Serious events: 11 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ramucirumab (IMC-1121B) and FOLFIRI
n=29 participants at risk
Treatment is sequential. Ramucirumab (IMC-1121B) was administered before FOLFIRI (Irinotecan + Folinic acid + 5-Fluorouracil) during Cycles 2+
Ramucirumab (IMC-1121B): 8 mg/kg, administered as IV infusion on Day 1 of each 2-week cycle (except Cycle 1)
Irinotecan: 180 mg/m² administered IV on Day 1 of each 2-week cycle
Folinic acid: 400 mg/m² administered IV on Day 1 of each 2-week cycle
5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of each 2-week cycle, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of each cycle
|
|---|---|
|
Gastrointestinal disorders
Ascites
|
3.4%
1/29 • Number of events 1 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Colonic fistula
|
3.4%
1/29 • Number of events 1 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
1/29 • Number of events 1 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
3.4%
1/29 • Number of events 1 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
3.4%
1/29 • Number of events 1 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.4%
1/29 • Number of events 4 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Clostridium difficile colitis
|
3.4%
1/29 • Number of events 1 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
10.3%
3/29 • Number of events 3 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
3.4%
1/29 • Number of events 1 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.9%
2/29 • Number of events 2 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.4%
1/29 • Number of events 1 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
3.4%
1/29 • Number of events 1 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Hallucination
|
3.4%
1/29 • Number of events 1 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.4%
1/29 • Number of events 1 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
6.9%
2/29 • Number of events 2 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.9%
2/29 • Number of events 2 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
Other adverse events
| Measure |
Ramucirumab (IMC-1121B) and FOLFIRI
n=29 participants at risk
Treatment is sequential. Ramucirumab (IMC-1121B) was administered before FOLFIRI (Irinotecan + Folinic acid + 5-Fluorouracil) during Cycles 2+
Ramucirumab (IMC-1121B): 8 mg/kg, administered as IV infusion on Day 1 of each 2-week cycle (except Cycle 1)
Irinotecan: 180 mg/m² administered IV on Day 1 of each 2-week cycle
Folinic acid: 400 mg/m² administered IV on Day 1 of each 2-week cycle
5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of each 2-week cycle, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of each cycle
|
|---|---|
|
Nervous system disorders
Dysgeusia
|
20.7%
6/29 • Number of events 6 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
17.2%
5/29 • Number of events 6 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Neuropathy peripheral
|
20.7%
6/29 • Number of events 9 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Tremor
|
6.9%
2/29 • Number of events 2 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Anxiety
|
6.9%
2/29 • Number of events 2 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Depression
|
6.9%
2/29 • Number of events 2 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
17.2%
5/29 • Number of events 6 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Nocturia
|
6.9%
2/29 • Number of events 2 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Proteinuria
|
24.1%
7/29 • Number of events 11 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
6.7%
1/15 • Number of events 3 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Testicular pain
|
6.7%
1/15 • Number of events 1 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
37.9%
11/29 • Number of events 14 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
6.9%
2/29 • Number of events 2 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
24.1%
7/29 • Number of events 7 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
10.3%
3/29 • Number of events 3 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
27.6%
8/29 • Number of events 9 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.3%
3/29 • Number of events 4 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
13.8%
4/29 • Number of events 6 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.3%
3/29 • Number of events 3 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.7%
6/29 • Number of events 7 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
6.9%
2/29 • Number of events 2 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.3%
3/29 • Number of events 3 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
10.3%
3/29 • Number of events 7 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.3%
3/29 • Number of events 4 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.9%
2/29 • Number of events 2 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
17.2%
5/29 • Number of events 6 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Anaemia
|
51.7%
15/29 • Number of events 48 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
10.3%
3/29 • Number of events 3 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Leukopenia
|
24.1%
7/29 • Number of events 18 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
17.2%
5/29 • Number of events 5 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Neutropenia
|
51.7%
15/29 • Number of events 28 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
31.0%
9/29 • Number of events 14 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal distension
|
13.8%
4/29 • Number of events 4 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
51.7%
15/29 • Number of events 23 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Ascites
|
6.9%
2/29 • Number of events 2 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
41.4%
12/29 • Number of events 17 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
69.0%
20/29 • Number of events 32 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dry mouth
|
10.3%
3/29 • Number of events 3 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.9%
2/29 • Number of events 2 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Flatulence
|
6.9%
2/29 • Number of events 2 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.9%
2/29 • Number of events 2 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gingival bleeding
|
6.9%
2/29 • Number of events 4 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Haematochezia
|
6.9%
2/29 • Number of events 2 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
58.6%
17/29 • Number of events 28 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Oral pain
|
13.8%
4/29 • Number of events 4 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Stomatitis
|
6.9%
2/29 • Number of events 4 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Tongue discolouration
|
6.9%
2/29 • Number of events 2 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
34.5%
10/29 • Number of events 14 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Asthenia
|
6.9%
2/29 • Number of events 2 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Chest pain
|
6.9%
2/29 • Number of events 2 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Chills
|
6.9%
2/29 • Number of events 2 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Fatigue
|
72.4%
21/29 • Number of events 45 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Mucosal inflammation
|
37.9%
11/29 • Number of events 16 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Oedema peripheral
|
24.1%
7/29 • Number of events 11 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.9%
2/29 • Number of events 2 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
6.9%
2/29 • Number of events 4 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Contusion
|
10.3%
3/29 • Number of events 3 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Alanine aminotransferase increased
|
10.3%
3/29 • Number of events 4 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Aspartate aminotransferase increased
|
27.6%
8/29 • Number of events 18 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood alkaline phosphatase increased
|
34.5%
10/29 • Number of events 13 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood creatinine increased
|
6.9%
2/29 • Number of events 6 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood lactate dehydrogenase increased
|
10.3%
3/29 • Number of events 3 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Haemoglobin decreased
|
6.9%
2/29 • Number of events 3 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Neutrophil count decreased
|
13.8%
4/29 • Number of events 7 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Weight decreased
|
34.5%
10/29 • Number of events 15 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
White blood cell count decreased
|
10.3%
3/29 • Number of events 5 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
51.7%
15/29 • Number of events 30 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dehydration
|
13.8%
4/29 • Number of events 4 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
20.7%
6/29 • Number of events 9 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
6.9%
2/29 • Number of events 2 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
48.3%
14/29 • Number of events 24 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
17.2%
5/29 • Number of events 7 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
24.1%
7/29 • Number of events 7 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
13.8%
4/29 • Number of events 6 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
13.8%
4/29 • Number of events 8 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
17.2%
5/29 • Number of events 5 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.8%
4/29 • Number of events 9 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.2%
5/29 • Number of events 8 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.9%
2/29 • Number of events 3 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.9%
2/29 • Number of events 2 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.9%
2/29 • Number of events 2 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
10.3%
3/29 • Number of events 4 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
13.8%
4/29 • Number of events 5 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.3%
3/29 • Number of events 5 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
13.8%
4/29 • Number of events 4 • Up To 2 Years
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER