Trial Outcomes & Findings for A Study to Assess the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram (NCT NCT00786838)
NCT ID: NCT00786838
Last Updated: 2014-04-11
Results Overview
QTc interval was measured by electrocardiograms to evaluate the potential effect of trabectedin on QTc interval duration. The Fridericia correction was used as the standard clinical correction for calculating the heart rate-corrected QT interval.
COMPLETED
PHASE2
76 participants
Baseline (predose on Day 1) to 24 hour post dose (Day 1 or Day 2)
2014-04-11
Participant Flow
This study was conducted in 7 countries: Belgium (3 sites), France (2 sites), India (2 sites), Republic of Korea (4 sites), Russia (4 sites), Spain (1 site), and the United States (4 sites). Total 75 participants were enrolled in this study.
All enrolled participants (ie, 75 participants) received study medication. 26 participants completed the study.
Participant milestones
| Measure |
Trabectedin
1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
|
|---|---|
|
Overall Study
STARTED
|
75
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
49
|
Reasons for withdrawal
| Measure |
Trabectedin
1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
|
|---|---|
|
Overall Study
Physician Decision
|
4
|
|
Overall Study
Death
|
4
|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Progressive disease
|
31
|
|
Overall Study
Withdrawal by Subject
|
4
|
Baseline Characteristics
A Study to Assess the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram
Baseline characteristics by cohort
| Measure |
Trabectedin
n=75 Participants
1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
|
|---|---|
|
Age, Continuous
|
50.2 years
STANDARD_DEVIATION 11.04 • n=39 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
White
|
51 participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Asian
|
23 participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=39 Participants
|
|
Region of Enrollment
Belgium
|
17 participants
n=39 Participants
|
|
Region of Enrollment
France
|
3 participants
n=39 Participants
|
|
Region of Enrollment
India
|
8 participants
n=39 Participants
|
|
Region of Enrollment
Republic Of Korea
|
15 participants
n=39 Participants
|
|
Region of Enrollment
Russia
|
17 participants
n=39 Participants
|
|
Region of Enrollment
Spain
|
4 participants
n=39 Participants
|
|
Region of Enrollment
United States Of America
|
11 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Baseline (predose on Day 1) to 24 hour post dose (Day 1 or Day 2)Population: All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.
QTc interval was measured by electrocardiograms to evaluate the potential effect of trabectedin on QTc interval duration. The Fridericia correction was used as the standard clinical correction for calculating the heart rate-corrected QT interval.
Outcome measures
| Measure |
Placebo
n=74 Participants
Placebo: Normal saline was administered as a 3-hour intravenous infusion on Day 1.
|
Trabectedin
n=74 Participants
1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2.
|
|---|---|---|
|
The Difference in the Change From Baseline (Predose on Day 1) in QTc Intervals Trabectedin Relative to Placebo at 24 Hour Post Dose by Fridericia Correction
|
3.6 milli seconds
Standard Deviation 10.08
|
-6.2 milli seconds
Standard Deviation 10.65
|
PRIMARY outcome
Timeframe: Baseline (predose on Day 1) to 24 hour post dose (Day 1 or Day 2)Population: All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.
QTc interval was measured by electrocardiograms to evaluate the potential effect of trabectedin on QTc interval duration. The Bazett's Correction was used as the standard clinical correction for calculating the heart rate-corrected QT interval.
Outcome measures
| Measure |
Placebo
n=74 Participants
Placebo: Normal saline was administered as a 3-hour intravenous infusion on Day 1.
|
Trabectedin
n=74 Participants
1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2.
|
|---|---|---|
|
The Difference in the Change From Baseline (Predose on Day 1) in QTc Intervals Trabectedin Relative to Placebo at 24 Hour Post Dose by Bazett's Correction
|
0.1 milli seconds
Standard Deviation 10.15
|
-1.5 milli seconds
Standard Deviation 13.61
|
SECONDARY outcome
Timeframe: Baseline (predose on Day 2) to 24 hour post dose (Day 2 or Day 3).Population: All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.
Outcome measures
| Measure |
Placebo
n=74 Participants
Placebo: Normal saline was administered as a 3-hour intravenous infusion on Day 1.
|
Trabectedin
1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2.
|
|---|---|---|
|
Maximum Plasma Concentration of Trabectedin (Cmax)
|
9.24 nanogram per milliliter
Standard Deviation 3.75
|
—
|
SECONDARY outcome
Timeframe: Baseline (predose on Day 2) to 24 hour post dose (Day 2 or Day 3).Population: All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.
Outcome measures
| Measure |
Placebo
n=74 Participants
Placebo: Normal saline was administered as a 3-hour intravenous infusion on Day 1.
|
Trabectedin
1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2.
|
|---|---|---|
|
Time Taken to Acheive Maximum Plasma Concentration (Tmax)
|
2.22 hours
Standard Deviation 0.65
|
—
|
SECONDARY outcome
Timeframe: Baseline (predose) to approximately 24 hour post dosePopulation: All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.
The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QT interval.
Outcome measures
| Measure |
Placebo
n=74 Participants
Placebo: Normal saline was administered as a 3-hour intravenous infusion on Day 1.
|
Trabectedin
n=74 Participants
1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2.
|
|---|---|---|
|
Number of Participants With QTc Interval Increase From Baseline (Predose on Day 1) Greater Than 30 Milli Seconds
QTcF greater than 30 milliseconds
|
2 participants
|
2 participants
|
|
Number of Participants With QTc Interval Increase From Baseline (Predose on Day 1) Greater Than 30 Milli Seconds
QTcB greater than 30 milliseconds
|
4 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Baseline (predose) to approximately 24 hour post dosePopulation: All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.
The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QT interval.
Outcome measures
| Measure |
Placebo
n=74 Participants
Placebo: Normal saline was administered as a 3-hour intravenous infusion on Day 1.
|
Trabectedin
n=74 Participants
1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2.
|
|---|---|---|
|
Number of Participants With QTc Interval Increase From Baseline (Predose on Day 1) Greater Than 60 Milli Seconds
QTcF greater than 60 milliseconds
|
0 participants
|
0 participants
|
|
Number of Participants With QTc Interval Increase From Baseline (Predose on Day 1) Greater Than 60 Milli Seconds
QTcB greater than 60 milliseconds
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline (predose) to approximately 24 hour post dosePopulation: All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.
The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QT interval.
Outcome measures
| Measure |
Placebo
n=74 Participants
Placebo: Normal saline was administered as a 3-hour intravenous infusion on Day 1.
|
Trabectedin
n=74 Participants
1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2.
|
|---|---|---|
|
Number of Participants With QTc Interval Greater Than 450 Milli Seconds
QTcF greater than 450 milliseconds
|
6 participants
|
4 participants
|
|
Number of Participants With QTc Interval Greater Than 450 Milli Seconds
QTcB greater than 450 milliseconds
|
21 participants
|
23 participants
|
SECONDARY outcome
Timeframe: Baseline (predose) to approximately 24 hour post dosePopulation: All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.
The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QTc interval.
Outcome measures
| Measure |
Placebo
n=74 Participants
Placebo: Normal saline was administered as a 3-hour intravenous infusion on Day 1.
|
Trabectedin
n=74 Participants
1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2.
|
|---|---|---|
|
Number of Participants With QTc Interval Greater Than 480 Milli Seconds
QTcF greater than 480 milli seconds
|
0 participants
|
0 participants
|
|
Number of Participants With QTc Interval Greater Than 480 Milli Seconds
QTcB greater than 480 milli seconds
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline (predose) to approximately 24 hour post dosePopulation: All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.
The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QTc interval.
Outcome measures
| Measure |
Placebo
n=74 Participants
Placebo: Normal saline was administered as a 3-hour intravenous infusion on Day 1.
|
Trabectedin
n=74 Participants
1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2.
|
|---|---|---|
|
Number of Participants With QTc Interval Greater Than 500 Milli Seconds
QTcF greater than 500 milli seconds
|
0 participants
|
0 participants
|
|
Number of Participants With QTc Interval Greater Than 500 Milli Seconds
QTcB greater than 500 milli seconds
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline (predose) to approximately 24 hour post dosePopulation: All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.
PR interval is the portion of the electrocardiogram between the onset of the P wave (atrial depolarization) and the QRS complex (ventricular depolarization).
Outcome measures
| Measure |
Placebo
n=74 Participants
Placebo: Normal saline was administered as a 3-hour intravenous infusion on Day 1.
|
Trabectedin
n=74 Participants
1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2.
|
|---|---|---|
|
Number of Participants With PR Interval Greater Than 200 Milli Seconds
|
3 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline (predose) to approximately 24 hour post dosePopulation: All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.
QRS interval is the interval from the beginning of the Q wave to the termination of the S wave, representing the time for ventricular depolarization.
Outcome measures
| Measure |
Placebo
n=74 Participants
Placebo: Normal saline was administered as a 3-hour intravenous infusion on Day 1.
|
Trabectedin
n=74 Participants
1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2.
|
|---|---|---|
|
Number of Participants With QRS Interval Greater Than 120 Milli Seconds
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline (predose on Day 1) to 24 hour post dosePopulation: All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order was excluded from evaluations. 73 participants analyzed in trabectedin group to derive the mean.
Outcome measures
| Measure |
Placebo
n=74 Participants
Placebo: Normal saline was administered as a 3-hour intravenous infusion on Day 1.
|
Trabectedin
n=73 Participants
1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2.
|
|---|---|---|
|
Mean Heart Rate (Beats Per Minute) Over 24 Hours Postdose
|
76.9 beats per minute
Standard Deviation 10.51
|
82.6 beats per minute
Standard Deviation 11.13
|
Adverse Events
Trabectedin
Serious adverse events
| Measure |
Trabectedin
n=75 participants at risk
1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.7%
2/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
1.3%
1/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.7%
5/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.3%
1/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.0%
6/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.3%
4/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
1/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Gastrointestinal disorders
Haematochezia
|
1.3%
1/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Gastrointestinal disorders
Nausea
|
2.7%
2/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Gastrointestinal disorders
Subileus
|
1.3%
1/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.3%
1/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
4/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
General disorders
Asthenia
|
5.3%
4/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
General disorders
Disease progression
|
1.3%
1/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
General disorders
Mucosal inflammation
|
1.3%
1/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
General disorders
Pyrexia
|
5.3%
4/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
2.7%
2/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
1.3%
1/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Infections and infestations
Cellulitis
|
1.3%
1/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Infections and infestations
Infection
|
1.3%
1/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Infections and infestations
Oral fungal infection
|
1.3%
1/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Infections and infestations
Sepsis
|
1.3%
1/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Infections and infestations
Wound infection
|
1.3%
1/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
1.3%
1/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.7%
2/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
1/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
4.0%
3/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue haemorrhage
|
1.3%
1/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
1.3%
1/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone sarcoma
|
1.3%
1/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer stage unspecified
|
1.3%
1/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
1.3%
1/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
1.3%
1/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Nervous system disorders
Syncope
|
1.3%
1/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Renal and urinary disorders
Hydronephrosis
|
1.3%
1/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Renal and urinary disorders
Renal failure
|
2.7%
2/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Renal and urinary disorders
Renal impairment
|
1.3%
1/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.3%
1/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Vascular disorders
Capillary leak syndrome
|
1.3%
1/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Vascular disorders
Embolism
|
1.3%
1/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Vascular disorders
Iliac artery occlusion
|
1.3%
1/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Vascular disorders
Vena cava thrombosis
|
1.3%
1/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
Other adverse events
| Measure |
Trabectedin
n=75 participants at risk
1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
29.3%
22/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.0%
9/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
41.3%
31/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
17.3%
13/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
5/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.3%
4/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Gastrointestinal disorders
Constipation
|
10.7%
8/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
5/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Gastrointestinal disorders
Nausea
|
50.7%
38/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
30/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
General disorders
Asthenia
|
32.0%
24/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
General disorders
Fatigue
|
22.7%
17/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
General disorders
Oedema peripheral
|
5.3%
4/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
General disorders
Pain
|
5.3%
4/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
General disorders
Pyrexia
|
10.7%
8/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
44.0%
33/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Metabolism and nutrition disorders
Anorexia
|
21.3%
16/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Metabolism and nutrition disorders
Enzyme abnormality
|
10.7%
8/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.0%
6/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
4/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Nervous system disorders
Dizziness
|
16.0%
12/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.7%
8/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
5/75 • Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
|
Additional Information
Senior Medical Director
Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60